Form 1 PRE-TED Form 2400

C

^{(Request for OMB approval will be submitted when form is complete)}

OMB No: 0915-0310

Expiration Date: 12/31/2013

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0310. Public reporting burden for this collection of information is estimated to average 0.85 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857.

Expiration date: 12/31/2013

IBMTR Use Only

Sequence Number:

Date Received:

Center Identification

CIBMTR Center Number: ___ ___ ___ ___ ___

EBMT Code (CIC): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Hospital:

Unit: (check only one)

 Adult

 Pediatric

Recipient Identification

CIBMTR Recipient ID (CRID): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Recipient Data

1. Date of birth: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

2. Sex:

 Male

 Female

3. Ethnicity:

 Hispanic or Latino

 Not Hispanic or Latino

 Not applicable (not a resident of the USA)

 Unknown

4. Race:

White

Black or African American

Asian

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Not reported

Unknown

Copy question 4 to report more than one race.

5. Zip or postal code for place of recipient’s residence (USA recipients only): ___ ___ ___ ___ ___

6. Is the recipient participating in a clinical trial?

 Yes - Go to question 7

 No – Go to question 11

7. Study Sponsor:

 BMT-CTN – Go to question 9

 RCI-BMT – Go to question 9

 USIDNET – Go to question 10

 COG – Go to question 10

 Other sponsor – Go to question 8

8. Specify other sponsor: ________________________________ - Go to question 10

9. Study ID Number: _______

10. Subject ID: ______________________

Copy questions 7-10 to report participation in more than one study.

Hematopoietic Cellular Transplant (HCT)

11. Date of this HCT: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

12. Was this the first HCT for this recipient?

 Yes – Go to question 13

 No – Go to question 15

13. Is a subsequent HCT planned as part of the overall treatment protocol (not as a reaction to post-HCT disease assessment)? (For autologous HCTs only)

 Yes – Go to question 14

 No – Go to question 29

14. Specify subsequent HCT planned:

 Autologous – Go to question 29

 Allogeneic – Go to question 29

15. Specify the number of prior HCTs: ___ ___

What was the prior HSC source(s)?

16. Autologous

 Yes

 No

17. Allogeneic, unrelated

 Yes

 No

18. Allogeneic, related

 Yes

 No

19. Syngeneic

 Yes

 No

20. Date of the last HCT (just before current HCT): ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

21. Was the last HCT performed at a different institution?

 Yes – Go to question 22

 No – Go to question 23

Specify the institution that performed the last HCT:

22. Name:

City:

State:

Country:

23. What was the HSC source for the last HCT?

 Autologous

 Allogeneic, unrelated donor

 Allogeneic, related donor

24. Reason for current HCT:

 No hematopoietic recovery – Go to question 29

 Partial hematopoietic recovery – Go to question 29

 Graft failure / rejection after achieving initial hematopoietic recovery – Go to question 25

 Persistent primary disease – Go to question 29

 Recurrent primary disease – Go to question 26

 Planned second HCT, per protocol – Go to question 29

 New malignancy (including PTLD and EBV lymphoma) – Go to question 27

 Stable, mixed chimerism – Go to question 29

 Declining chimerism – Go to question 29

 Other – Go to question 28

25. Date of graft failure / rejection: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

26. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

27. Date of secondary malignancy: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

28. Specify other reason:

Donor Information

29. Multiple donors?

 Yes – Go to question 30

 No - Go to question 31

30. Specify number of donors: ___ ___

To report more than one donor, copy questions 31- 62 and complete for each donor.

31. Specify donor:

 Autologous - Go to question 46

 Autologous cord blood unit - Go to question 35

 NMDP unrelated cord blood unit - Go to question 32

 NMDP unrelated donor - Go to question 33

 Related donor - Go to question 40

 Related cord blood unit - Go to question 35

 Non-NMDP unrelated donor - Go to question 34

 Non-NMDP unrelated cord blood unit - Go to question 35

32. NMDP cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ – Go to question 46

33. NMDP donor ID: ___ ___ ___ ___ — ___ ___ ___ ___ — ___ Go to question 46

34. Non-NMDP unrelated donor ID: (not applicable for related donors)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 38

35. Non-NMDP cord blood unit ID: (include related and autologous CBUs)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

36. Is the CBU ID also the ISBT DIN number?

 Yes – Go to question 38

 No – Go to question 37

37. Specify the ISBT DIN number: ____________________________________

38. Registry or UCB Bank ID: ___ ___ ___ ___ - If ‘Other registry’ go to 39, otherwise go to question 41

39. Specify other Registry or UCB Bank: - Go to question 41

40. Specify the related donor type:

 Syngeneic (monozygotic twin)

 HLA-identical sibling (may include non-monozygotic twin)

 HLA-matched other relative

 HLA-mismatched relative

41. Date of birth: (donor / infant)

 Known – Go to question 42

 Unknown – Go to question 43

42. Date of birth (donor / infant): ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 45

YYYY MM DD

43. Age: (donor / infant)

 Known – Go to question 44

 Unknown – Go to question 45

44. Age (donor / infant): ___ ___  Months (use only if less than 1 year old)

 Years

45. Sex: (donor / infant)

 Male

 Female

Specify product type:

46. Bone marrow:

 Yes

 No

47. PBSC:

 Yes

 No

48. Single cord blood unit:

 Yes

 No

49. Other product:

 Yes – Go to question 50

 No – Go to question 51

50. Specify other product type:

A series of collections should be considered a single product when they are all from the same donor and use the same collection method and technique (and mobilization, if applicable), even if the collections are performed on different days.

51. Specify number of products infused from this donor: ___ ___

Questions 52 – 59 are for autologous HCT recipients only. If other than autologous skip to question 60

52. Did the recipient have more than one mobilization event to acquire cells for HCT?

 Yes – Go to question 53

 No – Go to question 54

53. Specify the total number of mobilization events performed for this HCT (regardless of the number of collections or which collections were used for this HCT): ___

Specify all agents used in the mobilization events reported above:

54. GCSF

 Yes

 No

55. GM-CSF

 Yes

 No

56. Pegylated G-CSF

 Yes

 No

57. Plerixafor (Mozobil)

 Yes

 No

58. Other CXCR4 inhibitor

 Yes

 No

59. Combined with chemotherapy:

 Yes

 No

60. Was this donor used for any prior HCTs?

 Yes

 No

61. Donor CMV-antibodies (IgG or Total) (Allogeneic HCTs only)

 Reactive

 Non-reactive

 Not done

 Not applicable (cord blood unit)

62. Was plerixafor (Mozobil) given at any time prior to the preparative regimen? (Related HCTs only)

 Yes

 No

 Unknown

Consent

63. Has the recipient signed an IRB-approved consent form for submitting research data to the NMDP / CIBMTR?

 Yes (patient consented) – Go to question 64

 No (patient declined) – Go to question 65

 Not applicable (patient not approached) – Go to question 65

64. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

65. Has the recipient signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR?

 Yes (patient consented) – Go to question 66

 No (patient declined) - Go to question 67

 Not approached - Go to question 67

 Not applicable (center not participating) - Go to question 67

66. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

67. Has the donor signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR? (Related donors only)

 Yes (donor consented) – Go to question 68

 No (donor declined) - Go to question 69

 Not approached - Go to question 69

 Not applicable (center not participating) - Go to question 69

68. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Product Processing / Manipulation

69. Was the product manipulated prior to infusion?

 Yes - Go to questions 70

 No - Go to question 88

70. Specify portion manipulated:

 Entire product

 Portion of product

Specify all methods used to manipulate the product:

71. Washed

 Yes

 No

72. Diluted

 Yes

 No

73. Buffy coat enriched (buffy coat preparation)

 Yes

 No

74. B-cell reduced

 Yes

 No

75. CD8 reduced

 Yes

 No

76. Plasma reduced (removal)

 Yes

 No

77. RBC reduced

 Yes

 No

78. Cultured (ex-vivo expansion)

 Yes

 No

79. Genetic manipulation (gene transfer / transduction)

 Yes

 No

80. PUVA treated

 Yes

 No

81. CD34 enriched (CD34+ selection)

 Yes

 No

82. CD133 enriched

 Yes

 No

83. Monocyte enriched

 Yes

 No

84. Mononuclear cells enriched

 Yes

 No

85. T-cell depletion

 Yes

 No

86. Other cell manipulation

 Yes - Go to question 87

 No - Go to question 88

87. Specify other cell manipulation:

Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

88. What scale was used to determine the recipients functional status?

 Karnofsky scale (recipient age ≥ 16 years) – Go to question 89

 Lansky scale (recipient age < 16 years) – Go to question 90

Performance score prior to the preparative regimen:

89. Karnofsky Scale (recipient age ≥ 16 years):

 100 Normal; no complaints; no evidence of disease - Go to question 91

 90 Able to carry on normal activity - Go to question 91

 80 Normal activity with effort - Go to question 91

 70 Cares for self; unable to carry on normal activity or to do active work - Go to question 91

 60 Requires occasional assistance but is able to care for most needs - Go to question 91

 50 Requires considerable assistance and frequent medical care - Go to question 91

 40 Disabled; requires special care and assistance - Go to question 91

 30 Severely disabled; hospitalization indicated, although death not imminent - Go to question 91

 20 Very sick; hospitalization necessary - Go to question 91

 10 Moribund; fatal process progressing rapidly - Go to question 91

90. Lansky Scale (recipient age < 16 years):

 100 Fully active

 90 Minor restriction in physically strenuous play

 80 Restricted in strenuous play, tires more easily, otherwise active

 70 Both greater restrictions of, and less time spent in, active play

 60 Ambulatory up to 50% of time, limited active play with assistance / supervision

 50 Considerable assistance required for any active play; fully able to engage in quiet play

 40 Able to initiate quiet activities

 30 Needs considerable assistance for quiet activity

 20 Limited to very passive activity initiated by others (e.g., TV)

 10 Completely disabled, not even passive play

91. Recipient CMV-antibodies (IgG or Total) :

 Reactive

 Non-reactive

 Not done

Comorbid Conditions

This section is optional for non-U.S. Centers

92. Is there a history of mechanical ventilation?

 Yes

 No

93. Is there a history of proven invasive fungal infection?

 Yes

 No

94. Were there clinically significant co-existing diseases or organ impairment at time of patient assessment prior to preparative regimen? Source: Blood, 2005 Oct 15;106(8):2912-2919

 Yes - Go to questions 95

 No - Go to question 132

95. Arrhythmia — For example, any history of atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmias requiring treatment

 Yes

 No

 Unknown

96. Cardiac — Any history of coronary artery disease (one or more vessel-coronary artery stenosis requiring medical treatment, stent, or bypass graft), congestive heart failure, myocardial infarction, OR ejection fraction ≤ 50% on the most recent test

 Yes

 No

 Unknown

97. Cerebrovascular disease — Any history of transient ischemic attack, subarachnoid hemorrhage or cerebrovascular accident

 Yes

 No

 Unknown

98. Diabetes — Requiring treatment with insulin or oral hypoglycemics in the last 4 weeks but not diet alone

 Yes

 No

 Unknown

99. Heart valve disease — Except asymptomatic mitral valve prolapse

 Yes

 No

 Unknown

100. Hepatic, mild — Chronic hepatitis, bilirubin > upper limit of normal to 1.5 × upper limit of normal, or AST/ALT > upper limit of normal to 2.5 × upper limit of normal at the time of transplant OR any history of hepatitis B or hepatitis C infection

 Yes

 No

 Unknown

101. Hepatic, moderate / severe — Liver cirrhosis, bilirubin > 1.5 × upper limit of normal, or AST/ALT > 2.5 × upper limit of normal

 Yes

 No

 Unknown

102. Infection — For example, documented infection, fever of unknown origin, or pulmonary nodules requiring continuation of antimicrobial treatment after day 0

 Yes

 No

 Unknown

103. Inflammatory bowel disease — Any history of Crohn’s disease or ulcerative colitis requiring treatment

 Yes

 No

 Unknown

104. Obesity — Patients with a body mass index > 35 kg/m² at time of transplant

 Yes

 No

 Unknown

105. Peptic ulcer — Any history of peptic ulcer confirmed by endoscopy and requiring treatment

 Yes

 No

 Unknown

106. Psychiatric disturbance — For example, depression, anxiety, bipolar disorder or schizophrenia requiring psychiatric consult or treatment in the last 4 weeks

 Yes

 No

 Unknown

107. Pulmonary, moderate — Corrected diffusion capacity of carbon monoxide and/or FEV₁ 66-80% or dyspnea on slight activity at transplant

 Yes

 No

 Unknown

108. Pulmonary, severe — Corrected diffusion capacity of carbon monoxide and/or FEV₁ ≤ 65% or dyspnea at rest or requiring oxygen at transplant

 Yes

 No

 Unknown

109. Renal, moderate / severe — Serum creatinine > 2 mg/dL or > 177 μmol/L or on dialysis at transplant, OR prior renal transplantation

 Yes

 No

 Unknown

110. Rheumatologic — For example, any history of systemic lupus erythmatosis, rheumatoid arthritis, polymyositis, mixed connective tissue disease, or polymyalgia rheumatica requiring treatment (do NOT include degenerative joint disease, osteoarthritis)

 Yes

 No

 Unknown

111. Solid tumor, prior — Treated at any time point in the patient’s past history, excluding non-melanoma skin cancer, leukemia, lymphoma or multiple myeloma

 Yes – Go to question 112

 No – Go to question 130

 Unknown – Go to question 130

112. Breast cancer

 Yes – Go to question 113

 No – Go to question 114

113. Year of diagnosis: ___ ___ ___ ___

114. Central nervous system (CNS) malignancy (glioblastoma, astrocytoma)

 Yes – Go to question 115

 No – Go to question 116

115. Year of diagnosis: ___ ___ ___ ___

116. Gastrointestinal malignancy (colon, rectum, stomach, pancreas, intestine)

 Yes – Go to question 117

 No – Go to question 118

117. Year of diagnosis: ___ ___ ___ ___

118. Genitourinary malignancy (kidney, bladder, ovary, testicle, genitalia, uterus, cervix)

 Yes – Go to question 119

 No – Go to question 120

119. Year of diagnosis: ___ ___ ___ ___

120. Lung cancer

 Yes – Go to question 121

 No – Go to question 122

121. Year of diagnosis: ___ ___ ___ ___

122. Melanoma

 Yes – Go to question 123

 No – Go to question 124

123. Year of diagnosis: ___ ___ ___ ___

124. Oropharyngeal cancer (tongue, buccal mucosa)

 Yes – Go to question 125

 No – Go to question 126

125. Year of diagnosis: ___ ___ ___ ___

126. Sarcoma

 Yes – Go to question 127

 No – Go to question 128

127. Year of diagnosis: ___ ___ ___ ___

128. Thyroid cancer

 Yes – Go to question 129

 No – Go to question 130

129. Year of diagnosis: ___ ___ ___ ___

130. Other co-morbid condition

 Yes – Go to question 131

 No – Go to question 132

 Unknown – Go to question 132

131. Specify other co-morbid condition:

132. Was there a history of malignancy (hematologic or non-melanoma skin cancer) other than the primary disease for which this HCT is being performed?

 Yes – Go to question 133

 No – Go to question 153

Specify which malignancy(ies) occurred:

133. Acute myeloid leukemia (AML / ANLL)

 Yes – Go to question 134

 No – Go to question 135

134. Year of diagnosis: ___ ___ ___ ___

135. Other leukemia, including ALL

 Yes – Go to questions 136

 No – Go to question 138

136. Year of diagnosis: ___ ___ ___ ___

137. Specify leukemia:

138. Clonal cytogenetic abnormality without leukemia or MDS

 Yes – Go to question 139

 No – Go to question 140

139. Year of diagnosis: ___ ___ ___ ___

140. Hodgkin disease

 Yes – Go to question 141

 No – Go to question 12

141. Year of diagnosis: ___ ___ ___ ___

142. Lymphoma or lymphoproliferative disease

 Yes – Go to questions 143

 No – Go to question 145

143. Year of diagnosis: ___ ___ ___ ___

144. Was the tumor EBV positive?

 Yes

 No

145. Other skin malignancy (basal cell, squamous)

 Yes – Go to questions 146

 No – Go to question 148

146. Year of diagnosis: ___ ___ ___ ___

147. Specify other skin malignancy:

148. Myelodysplasia (MDS) / myeloproliferative (MPN) disorder

 Yes – Go to question 149

 No – Go to question 150

149. Year of diagnosis: ___ ___ ___ ___

150. Other prior malignancy

 Yes – Go to questions 151

 No – Go to question 153

151. Year of diagnosis: ___ ___ ___ ___

152. Specify other prior malignancy:

Pre-HCT Preparative Regimen (Conditioning)

153. Height at initiation of pre-HCT preparative regimen: ___ ___ ___  inches

 centimeters

154. Actual weight at initiation of pre-HCT preparative regimen: ___ ___ ___  pounds

 kilograms

155. Was a pre-HCT preparative regimen prescribed?

 Yes – Go to questions 156

 No – Go to question 316

156. Classify the recipient’s prescribed preparative regimen:

 Myeloablative

 Non-myeloablative (NST)

 Reduced intensity (RIC)

157. Date pre-HCT preparative regimen began (irradiation or drugs): ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

(Use earliest date from questions 161 radiation, or 166 – 315 chemotherapy)

158. Was irradiation planned as part of the pre-HCT preparative regimen?

 Yes – Go to question 159

 No – Go to question 166

159. What was the prescribed radiation field?

 Total body

 Total body by tomotherapy

 Total lymphoid or nodal regions

 Thoracoabdominal region

160. Total prescribed dose: (dose per fraction x total number of fractions) ___ ___ ___ ___  Gy

 cGy

161. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

162. Was the radiation fractionated?

 Yes – Go to questions 163

 No – Go to question 166

163. Prescribed dose per fraction: ___ ___ ___  Gy

 cGy

164. Number of days: (include “rest” days) ___

165. Total number of fractions: ___ ___

Indicate the total prescribed cumulative dose for the preparative regimen:

166. ALG, ALS, ATG, ATS

 Yes – Go to questions 167

 No – Go to question 171

167. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

168. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

169. Specify source:

 Horse – Go to question 171

 Rabbit – Go to question 171

 Other source – Go to question 170

170. Specify other source:

171. Anthracycline

 Yes – Go to question 172

 No – Go to question 188

172. Daunorubicin

 Yes – Go to questions 173

 No – Go to question 175

173. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

174. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

175. Doxorubicin (Adriamycin)

 Yes – Go to questions 176

 No – Go to question 178

176. Total prescribed dose: ___ ___ ___ ___  mg/m²

 mg/kg

177. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

178. Idarubicin

 Yes – Go to questions 179

 No – Go to question 181

179. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

180. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

181. Rubidazone

 Yes – Go to questions 182

 No – Go to question 184

182. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

183. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

184. Other anthracycline

 Yes – Go to questions 185

 No – Go to question 188

185. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

186. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

187. Specify other anthracycline:

188. Bleomycin (BLM, Blenoxane)

 Yes – Go to questions 189

 No – Go to question 191

189. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

190. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

191. Busulfan (Myleran)

 Yes – Go to questions 192

 No – Go to question 197

192. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

193. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

194. Specify administration:

 Oral

 IV

 Both

195. Were pharmacokinetics performed to determine preparative regimen drug dosing?

 Yes – Go to question 196

 No – Go to question 197

196. Specify the target AUC: ___ ___ ___ ___ µMol x min/L

197. Carboplatin

 Yes – Go to questions 198

 No – Go to question 202

198. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

199. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

200. Were pharmacokinetics performed to determine preparative regimen drug dosing?

 Yes – Go to question 201

 No – Go to question 202

201. Specify the target AUC: ___ ___ ___mg/mL/minute

202. Cisplatin (Platinol, CDDP)

 Yes – Go to questions 203

 No – Go to question 205

203. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

204. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

205. Cladribine (2-CdA, Leustatin)

 Yes – Go to questions 206

 No – Go to question 208

206. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

207. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

208. Corticosteroids (excluding anti-nausea medication)

 Yes – Go to question 209

 No – Go to question 222

209. Methylprednisolone (Solu-Medrol)

 Yes – Go to questions 210

 No – Go to question 212

210. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

211. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

212. Prednisone

 Yes – Go to questions 213

 No – Go to question 215

213. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

214. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

215. Dexamethasone

 Yes – Go to questions 216

 No – Go to question 218

216. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

217. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

218. Other corticosteroid

 Yes – Go to questions 219

 No – Go to question 222

219. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

220. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

221. Specify other corticosteroid:

222. Cyclophosphamide (Cytoxan)

 Yes – Go to questions 223

 No – Go to question 225

223. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

224. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

225. Cytarabine (Ara-C)

 Yes – Go to questions 226

 No – Go to question 228

226. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

227. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

228. Etoposide (VP-16, VePesid)

 Yes – Go to questions 229

 No – Go to question 231

229. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

230. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

231. Fludarabine

 Yes – Go to questions 232

 No – Go to question 234

232. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

233. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

234. Ifosfamide

 Yes – Go to questions 235

 No – Go to question 237

235. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

236. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

237. Intrathecal chemotherapy

 Yes – Go to question 238

 No – Go to question 251

238. Intrathecal cytarabine (IT Ara-C)

 Yes – Go to questions 239

 No – Go to question 241

239. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

240. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

241. Intrathecal methotrexate (IT MTX)

 Yes – Go to questions 242

 No – Go to question 244

242. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

243. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

244. Intrathecal thiotepa

 Yes – Go to questions 245

 No – Go to question 247

245. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

246. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

247. Other intrathecal drug

 Yes – Go to questions 248

 No – Go to question 251

248. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

249. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

250. Specify other intrathecal drug:

251. Melphalan (L-Pam)

 Yes – Go to questions 252

 No – Go to question 255

252. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

253. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

254. Specify administration:

 Oral

 IV

 Both

255. Mitoxantrone

 Yes – Go to questions 256

 No – Go to question 258

256. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

257. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

258. Monoclonal antibody

 Yes – Go to question 259

 No – Go to question 279

259. Radio labeled mAb

 Yes – Go to questions 250

 No – Go to question 266

260. Total prescribed dose of radioactive component: ___ ___ ___ ___ ● ___  mCi

 MBq

261. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Specify radio labeled mAb:

262. Tositumomab (Bexxar)

 Yes

 No

263. Ibritumomab tiuxetan (Zevalin)

 Yes

 No

264. Other radio labeled mAb

 Yes – Go to question 265

 No – Go to question 266

265. Specify radio labeled mAb:

266. Alemtuzumab (Campath)

 Yes – Go to questions 267

 No – Go to question 269

267. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

268. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

269. Rituximab (Rituxan, anti CD20)

 Yes – Go to questions 270

 No – Go to question 272

270. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

271. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

272. Gemtuzumab (Mylotarg, anti CD33)

 Yes – Go to questions 273

 No – Go to question 275

273. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

274. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

275. Other mAb

 Yes – Go to questions 276

 No – Go to question 279

276. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

277. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

278. Specify other mAb:

279. Nitrosourea

 Yes – Go to question 280

 No – Go to question 290

280. Carmustine (BCNU)

 Yes – Go to questions 281

 No – Go to question 283

281. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

282. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

283. CCNU (Lomustine)

 Yes – Go to questions 284

 No – Go to question 286

284. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

285. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

286. Other nitrosourea

 Yes – Go to questions 287

 No – Go to question 290

287. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

288. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

289. Specify other nitrosourea:

290. Paclitaxel (Taxol, Xyotax)

 Yes – Go to questions 291

 No – Go to question 293

291. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

292. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

293. Teniposide (VM26)

 Yes – Go to questions 294

 No – Go to question 296

294. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

295. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

296. Thiotepa

 Yes – Go to questions 297

 No – Go to question 299

297. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

298. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

299. Treosulfan

 Yes – Go to questions 300

 No – Go to question 302

300. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

301. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

302. Tyrosine kinase inhibitors

 Yes – Go to questions 303

 No – Go to question 312

303. Dasatinib (Sprycel)

 Yes – Go to questions 304

 No – Go to question 306

304. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

305. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

306. Imatinib mesylate (STI571, Gleevec)

 Yes – Go to questions 307

 No – Go to question 309

307. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

308. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

309. Nilotinib

 Yes – Go to questions 310

 No – Go to question 312

310. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

311. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

312. Other drug

 Yes – Go to questions 313

 No – Go to question 316

313. Total prescribed dose ___ ___ ___ ___  mg/m²

 mg/kg

314. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

315. Specify other drug:

GVHD Prophylaxis

This section is to be completed for allogeneic HCTs only; autologous HCTs continue with question 342.

316. Was GVHD prophylaxis planned / given?

 Yes - Go to questions 317

 No - Go to question 342

Specify:

317. ALG, ALS, ATG, ATS

 Yes – Go to question 318

 No – Go to question 320

318. Specify source:

 Horse – Go to question 320

 Rabbit – Go to question 320

 Other source – Go to question 319

319. Specify other source:

320. Corticosteroids (systemic)

 Yes

 No

321. Cyclosporine (CSA, Neoral, Sandimmune)

 Yes

 No

322. Cyclophosphamide (Cytoxan)

 Yes

 No

323. ECP (extra-corporeal photopheresis)

 Yes

 No

324. FK 506 (Tacrolimus, Prograf)

 Yes

 No

325. In vivo monoclonal antibody

 Yes – Go to question 326

 No – Go to question 333

Specify in vivo monoclonal antibody:

326. Alemtuzumab (Campath)

 Yes

 No

327. Anti CD 25 (Zenapax, Daclizumab, AntiTAC)

 Yes – Go to question 328

 No – Go to question 329

328. Specify:

329. Etanercept (Enbrel)

 Yes

 No

330. Infliximab (Remicade)

 Yes

 No

331. Other in vivo monoclonal antibody

 Yes – Go to question 332

 No – Go to question 333

332. Specify antibody:

333. In vivo immunotoxin

 Yes – Go to question 334

 No – Go to question 335

334. Specify immunotoxin:

335. Methotrexate (MTX) (Amethopterin)

 Yes

 No

336. Mycophenolate mofetil (MMF) (CellCept)

 Yes

 No

337. Sirolimus (Rapamycin, Rapamune)

 Yes

 No

338. Blinded randomized trial

 Yes – Go to question 339

 No – Go to question 340

339. Specify trial agent:

340. Other agent

 Yes – Go to question 341

 No – Go to question 342

341. Specify other agent:

Other Toxicity Modifying Regimen

Optional for non-U.S. Centers

342. Was KGF (palifermin, Kepivance) started or is there a plan to use it?

 Yes

 No

 Masked trial

Post-HCT Disease Therapy Planned as of Day 0

343. Is this HCT part of a planned multiple (sequential) graft / HCT protocol?

 Yes

 No

344. Is additional post-HCT therapy planned?

 Yes - Go to questions 345

 No - Go to question 356

Questions 345 – 355 are optional for non-U.S. centers

345. Bortezomib (Velcade)

 Yes

 No

346. Cellular therapy (e.g. DCI, DLI)

 Yes

 No

347. Dexamethosone

 Yes

 No

348. Intrathecal chemotherapy

 Yes

 No

349. Tyrosine kinase inhibitor (e.g. imatinib mesylate)

 Yes

 No

350. Lenalidomide (Revlimid)

 Yes

 No

351. Local radiotherapy

 Yes

 No

352. Rituximab (Rituxan, Mabthera)

 Yes

 No

353. Thalidomide (Thalomid)

 Yes

 No

354. Other planned therapy

 Yes – Go to question 355

 No – Go to question 356

355. Specify other planned therapy:

Primary Disease for HCT

356. Date of diagnosis of primary disease for HCT: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

357. What was the primary disease for which the HCT was performed?

 Acute myelogenous leukemia (AML or ANLL) (10) - Go to question 358

 Acute lymphoblastic leukemia (ALL) (20) - Go to question 419

 Other acute leukemia (80) - Go to question 462

 Chronic myelogenous leukemia (CML) (40) - Go to question 466

 Myelodysplastic (MDS) / myeloproliferative (MPN) diseases (50) (Please classify all pre-leukemias)
(If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 480

 Other leukemia (30) (includes CLL) - Go to question 573

 Hodgkin lymphoma (150) - Go to question 580

 Non-Hodgkin lymphoma (100) - Go to question 583

 Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 589

 Solid tumors (200) - Go to question 621

 Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 622

 Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 623

 Disorders of the immune system (400) - Go to question 624

 Inherited abnormalities of platelets (500) - Go to question 625

 Inherited disorders of metabolism (520) - Go to question 626

 Histiocytic disorders (570) - Go to question 627

 Autoimmune diseases (600) - Go to question 628

 Other disease (900) - Go to question 629

Acute Myelogenous Leukemia (AML)

358. Specify the AML classification:

 AML with t(9;11) (p22;q23); MLLT 3-MLL (5)

 AML with t(6;9) (p23;q24); DEK-NUP214 (6)

 AML with inv(3) (q21;q26.2) or t(3;3) (q21;q26.2); RPN1-EVI1 (7)

 AML (megakaryoblastic) with t(1;22) (p13;q13); RBM15-MKL1 (8)

 AML with t(8;21); (q22; q22); RUNX1/RUNX1T1 (281)

 AML with inv(16); (p13;1q22) or t(16;16) (p13.1; q22); CBFB/MYH11 (282)

 APL with t(15;17); (q22;q12); RARA;PML (283)

 AML with 11q23 (MLL) abnormalities (i.e., t(4;11), t(6;11), t(9;11), t(11;19)) (284)

 AML with myelodysplasia – related changes (285)

 Therapy related AML (t-AML) (9)

 Myeloid sarcoma (295)

 Blastic plasmacytoid dendritic cell neoplasm (296)

 AML or ANLL, not otherwise specified (280)

 AML with multi-lineage dysplasia (285)

 AML, minimally differentiated (M0) (286)

 AML without maturation (M1) (287)

 AML with maturation (M2) (288)

 Acute myelomonocytic leukemia (M4) (289)

 Acute monoblastic / acute monocytic leukemia (M5) (290)

 Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (M6) (291)

 Acute megakaryoblastic leukemia (M7) (292)

 Acute basophilic leukemia (293)

 Acute panmyelosis with myelofibrosis (294)

359. Did AML transform from MDS or MPN?

 Yes – Also complete Disease Classification questions 480-527

 No

360. Was the disease (AML) therapy related?

 Yes

 No

 Unknown

361. Did the recipient have a predisposing condition?

 Yes - Go to question 362

 No - Go to question 364

 Unknown - Go to question 364

362. Specify condition:

 Bloom syndrome - Go to question 364

 Down syndrome - Go to question 364

 Fanconi anemia - Go to question 364 - Also complete CIBMTR Form 2029 – FAN

 Neurofibromatosis type 1 - Go to question 364

 Other condition - Go to question 363

363. Specify other condition: __________________________________________

364. Were cytogenetics tested (conventional or FISH)?

 Yes - Go to question 365

 No - Go to question 402

 Unknown - Go to question 402

365. Results of tests:

 Abnormalities identified – Go to question 366

 No evaluable metaphases - Go to question 402

 No abnormalities - Go to question 402

Specify cytogenetic abnormalities identified at any time prior to the start of the preparative regimen:

Monosomy

366. –5

Yes

No

367. –7

Yes

No

368. –17

Yes

No

369. –18

Yes

No

370. –X

Yes

No

371. –Y

Yes

No

Trisomy

372. +4

Yes

No

373. +8

Yes

No

374. +11

Yes

No

375. +13

Yes

No

376. +14

Yes

No

377. +21

Yes

No

378. +22

Yes

No

Translocation

379. t(3;3)

Yes

No

380. t(6;9)

Yes

No

381. t(8;21)

Yes

No

382. t(9;11)

Yes

No

383. t(9;22)

Yes

No

384. t(15;17) and variants

Yes

No

385. t(16;16)

Yes

No

Deletion

386. del(3q) / 3q–

Yes

No

387. del(5q) / 5q–

Yes

No

388. del(7q) / 7q–

Yes

No

389. del(9q) / 9q–

Yes

No

390. del(11q) / 11q–

Yes

No

391. del(16q) / 16q–

Yes

No

392. del(17q) / 17q–

Yes

No

393. del(20q) / 20q–

Yes

No

394. del(21q) / 21q–

Yes

No

Inversion

395. inv(3)

Yes

No

396. inv(16)

Yes

No

Other

397. (11q23) any abnormality

Yes

No

398. 12p any abnormality

Yes

No

399. Complex - ≥ 3 distinct abnormalities

Yes

No

400. Other abnormality

Yes - Go to question 401

No - Go to question 402

401. Specify other abnormality: __________________________________

402. Were tests for molecular markers performed (e.g. PCR)?

 Yes – Go to question 403

 No – Go to question 412

 Unknown – Go to question 412

Specify molecular markers identified at any time prior to the start of the preparative regimen:

403. CEBPA

 Positive

 Negative

 Not done

404. FLT3 – D835 point mutation

 Positive

 Negative

 Not done

405. FLT3 – ITD mutation

 Positive

 Negative

 Not done

406. IDH1

 Positive

 Negative

 Not done

407. IDH2

 Positive

 Negative

 Not done

408. KIT

 Positive

 Negative

 Not done

409. NPM1

 Positive

 Negative

 Not done

410. Other molecular marker

 Positive- Go to question 411

 Negative- Go to question 411

 Not done- Go to question 412

411. Specify other molecular marker: _________________________________

Status at transplantation

412. What was the disease status (based on hematologic test results)?

 Primary induction failure (PIF) – Go to question 418

 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 413

 2nd complete remission – Go to question 413

 ≥ 3rd complete remission – Go to question 413

 1st relapse – Go to question 417

 2nd relapse – Go to question 417

 ≥ 3rd relapse – Go to question 417

 No treatment – Go to question 418

413. How many cycles of induction therapy were required to achieve CR?

1

2

≥ 3

414. Was the recipient in molecular remission?

Yes

No

Unknown

Not applicable

415. Was the recipient in remission by flow cytometry?

Yes

No

Unknown

Not applicable

416. Was the recipient in cytogenetic remission?

Yes – Go to question 418

No – Go to question 418

Unknown – Go to question 418

Not applicable– Go to question 418

417. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

418. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Acute Lymphoblastic Leukemia (ALL)

419. Specify ALL classification:

 t(9;22)(q34;q11); BCR/ABL1 (192)

 t(v;11q23); MLL rearranged (193)

 t(1;19)(q23;p13) TCF3-PBX1 (194)

 t(12;21) (p12;q22); TEL-AML1 (195)

 t(5;14) (q31;q32); IL3-IGH (81)

 Hyperdiploidy (51-65 chromosomes) (82)

 Hypodiploidy (<45 chromosomes) (83)

 B-cell ALL, NOS {L1/L2} (191)

 T-cell lymphoblastic leukemia / lymphoma (Precursor T-cell ALL) (196)

 ALL, NOS (190)

420. Were tyrosine kinase inhibitors (i.e.imatinib mesylate) given for pre-HCT therapy at any time prior to start of the preparative regimen?

 Yes

 No

 Unknown

421. Were cytogenetics tested (conventional or FISH)?

 Yes - Go to question 422

 No - Go to question 450

 Unknown - Go to question 450

422. Results of tests:

 Abnormalities identified – Go to question 423

 No evaluable metaphases - Go to question 450

 No abnormalities - Go to question 450

Specify cytogenetic abnormalities identified at any time prior to the start of the preparative regimen.

Monosomy

423. –7

 Yes

 No

Trisomy

424. +4

 Yes

 No

425. +8

 Yes

 No

426. +17

 Yes

 No

427. +21

 Yes

 No

Translocation

428. t(1;19)

 Yes

 No

429. t(2;8)

 Yes

 No

430. t(4;11)

 Yes

 No

431. t(5;14)

 Yes

 No

432. t(8;14)

 Yes

 No

433. t(8;22)

 Yes

 No

434. t(9;22)

 Yes

 No

435. t(10;14)

 Yes

 No

436. t(11;14)

 Yes

 No

437. t(12;21)

 Yes

 No

Deletion

438. del(6q) / 6q–

 Yes

 No

439. del(9p) / 9p–

 Yes

 No

440. del(12p) / 12p–

 Yes

 No

Addition

441. add(14q)

 Yes

 No

Other

442. (11q23) any abnormality

 Yes

 No

443. 9p any abnormality

 Yes

 No

444. 12p any abnormality

 Yes

 No

445. Hyperdiploid (> 50)

 Yes

 No

446. Hypodiploid (< 46)

 Yes

 No

447. Complex - ≥3 distinct abnormalities

 Yes

 No

448. Other abnormality

 Yes - Go to question 449

 No - Go to question 450

449. Specify other abnormality: ___________________________

450. Were tests for molecular markers performed (e.g. PCR)?

 Yes – Go to question 451

 No – Go to question 455

 Unknown – Go to question 455

Specify molecular markers identified at any time prior to the start of the preparative regimen:

451. BCR / ABL

 Positive

 Negative

 Not done

452. TEL-AML / AML1

 Positive

 Negative

 Not done

453. Other molecular marker

 Positive – Go to question 454

 Negative – Go to question 454

 Not done – Go to question 455

454. Specify other molecular marker:

Status at Transplantation:

455. What was the disease status (based on hematologic test results)?

 Primary induction failure – Go to question 461

 1st complete remission (no previous marrow or extramedullary relapse) – Go to question 456

 2nd complete remission – Go to question 456

 ≥ 3rd complete remission – Go to question 456

 1st relapse – Go to question 460

 2nd relapse – Go to question 460

 ≥ 3rd relapse – Go to question 460

 No treatment – Go to question 461

456. How many cycles of induction therapy were required to achieve CR?

1

2

≥ 3

457. Was the recipient in molecular remission?

Yes

No

Unknown

Not applicable

458. Was the recipient in remission by flow cytometry?

Yes

No

Unknown

Not applicable

459. Was the recipient in cytogenetic remission?

Yes – Go to question 461

No – Go to question 461

Unknown – Go to question 461

Not applicable – Go to question 461

460. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

461. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Other Acute Leukemia

462. Specify other acute leukemia classification:

 Acute undifferentiated leukemia (31) - Go to question 464

 Biphenotypic, bilineage or hybrid leukemia (32) - Go to question 464

 Acute mast cell leukemia (33) - Go to question 464

 Other acute leukemia (89) - Go to question 463

463. Specify other acute leukemia:

Status at Transplantation:

464. What was the disease status (based on hematologic test results)?

 Primary induction failure

 1st complete remission (no previous marrow or extramedullary relapse)

 2nd complete remission

 ≥ 3rd complete remission

 1st relapse

 2nd relapse

 ≥3rd relapse

 No treatment

465. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Chronic Myelogenous Leukemia (CML)

Philadelphia chromosome+, Ph+, t(9;22)(q34;q11), or variant OR bcr/abl+

466. Specify CML classification:

 Ph+ / bcr+ (41)

 Ph+ / bcr- (42)

 Ph+ / bcr unknown (43)

 Ph- / bcr+ (44)

 Ph unknown / bcr+ (47)

467. Was therapy given prior to this HCT?

 Yes - Go to questions 468

 No - Go to question 474

468. Combination chemotherapy

 Yes

 No

469. Hydroxyurea (HU)

 Yes

 No

470. Tyrosine kinase inhibitor (e.g.imatinib mesylate, dasatinib, nilotinib)

 Yes

 No

471. Interferon-α (Intron, Roferon)

 Yes

 No

472. Other therapy

 Yes - Go to question 473

 No - Go to question 44

473. Specify other therapy: ______________________________________

474. What was the disease status at last evaluation prior to the start of the preparative regimen?

 Complete hematologic remission - Go to questions 475

 First chronic phase – Go to question 479

 Second or greater chronic phase – Go to question 478

 Accelerated phase - Go to question 478

 Blast crisis - Go to question 478

Specify remission:

475. Cytogenetic complete remission (Ph negative)

 Yes

 No

 Unknown

476. Molecular complete remission (BCR / ABL negative)

 Yes

 No

 Unknown

477. CML disease status before treatment that achieved this CR:

 Chronic phase - Go to question 478

 Accelerated phase - Go to question 478

 Blast phase - Go to question 478

478. Number

 1st - Go to question 476

 2nd - Go to question 476

 3rd or higher - Go to question 476

479. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

480. What was the MDS / MPN classification at diagnosis? – If transformed to AML, indicate AML as primary disease; also complete Disease Classification questions 358-418

 Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51)

 Refractory anemia with ringed sideroblasts (RARS) (55)

 Refractory anemia with excess blasts-1 (RAEB-1) (61)

 Refractory anemia with excess blasts-2 (RAEB-2) (62)

 Refractory cytopenia with multilineage dysplasia (RCMD) (64)

 Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68)

 Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)

 Myelodysplastic syndrome (MDS), unclassifiable (50)

 Chronic neutrophilic leukemia (165)

 Chronic eosinophilic leukemia, NOS (166)

 Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)

 Polycythemia vera (PCV) (57)

 Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)

 Myeloproliferative neoplasm (MPN), unclassifiable (60)

 Chronic myelomonocytic leukemia (CMMoL) (54)

 Juvenile myelomonocytic leukemia (JMML/JCML) (36) – Go to First Name

 Atypical chronic myeloid leukemia, Ph-/bcr/abl- {CML, NOS} (45) - Go to question 577

 Atypical chronic myeloid leukemia, Ph-/bcr unknown {CML, NOS} (46) - Go to question 577

 Atypical chronic myeloid leukemia, Ph unknown/bcr- {CML, NOS} (48) - Go to question 577

 Atypical chronic myeloid leukemia, Ph unknown/bcr unknown {CML, NOS} (49) - Go to question 577

 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

481. Was the disease (MDS/MPN) therapy related?

 Yes

 No

 Unknown

482. Did the recipient have a predisposing condition?

 Yes – Go to question 483

 No – Go to question 485

 Unknown – Go to question 485

483. Specify condition:

 Aplastic anemia – Go to question 485- Also complete CIBMTR form 2028 - APL

 Bloom syndrome – Go to question 485

 Down syndrome – Go to question 485

 Fanconi anemia – – Go to question 485 - Also complete CIBMTR form 2029 - FAN

 Other condition – Go to question 484

484. Specify other condition:

Laboratory Studies at Diagnosis of MDS

485. WBC

 Known – Go to question 486

 Unknown– Go to question 487

486. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

487. Hemoglobin

 Known – Go to question 488

 Unknown – Go to question 490

488. ___ ___ ___ ___ ● ___ ___  g/dL

 g/L

 mmol/L

489. Was RBC transfused < 30 days before date of test?

 Yes

 No

490. Platelets

 Known – Go to question 491

 Unknown – Go to question 493

491. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

492. Were platelets transfused < 7 days before date of test?

 Yes

 No

493. Neutrophils

 Known – Go to question 494

 Unknown – Go to question 495

494. ___ ___%

495. Blasts in bone marrow

 Known – Go to question 496

 Unknown – Go to question 497

496. ___ ___ ___ %

497. Were cytogenetics tested (conventional or FISH)?

 Yes – Go to question 498

 No – Go to question 525

 Unknown – Go to question 525

498. Results of test:

 Abnormalities identified – Go to question 499

 No evaluable metaphases – Go to question 525

 No abnormalities – Go to question 525

Specify abnormalities identified at diagnosis:

499. Specify number of distinct cytogenetic abnormalities:

 One (1)

 Two (2)

 Three (3)

 Four or more (4 or more)

Monosomy

500. –5

 Yes

 No

501. –7

 Yes

 No

502. –13

 Yes

 No

503. –20

 Yes

 No

504. –Y

 Yes

 No

Trisomy

505. +8

 Yes

 No

506. +19

 Yes

 No

Translocation

507. t(1;3)

 Yes

 No

508. t(2;11)

 Yes

 No

509. t(3;3)

 Yes

 No

510. t(3;21)

 Yes

 No

511. t(6;9)

 Yes

 No

512. t(11;16)

 Yes

 No

Deletion

513. del(3q) / 3q-

 Yes

 No

514. del(5q) / 5q-

 Yes –

 No

515. del(7q) / 7q-

 Yes

 No

516. del(9q) / 9q-

 Yes

 No

517. del(11q) / 11q-

 Yes

 No

518. del(12p) / 12p-

 Yes

 No

519. del(13q) / 13q-

 Yes

 No

520. del(20q) / 20q-

 Yes

 No

Inversion

521. inv(3)

 Yes

 No

Other

522. i17q

 Yes

 No

523. Other abnormality

 Yes – Go to question 524

 No – Go to question 525

524. Specify other abnormality:

525. Did the recipient progress or transform to a different MDS / MPN subtype between diagnosis and the start of the preparative regimen?

 Yes – Go to question 526

 No – Go to question 528

526. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

527. Specify the MDS / MPN classification after transformation:

 Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51)

 Refractory anemia with ringed sideroblasts (RARS) (55)

 Refractory anemia with excess blasts-1 (RAEB-1) (61)

 Refractory anemia with excess blasts-2 (RAEB-2) (62)

 Refractory cytopenia with multilineage dysplasia (RCMD) (64)

 Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68)

 Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)

 Myelodysplastic syndrome (MDS), unclassifiable (50)

 Chronic neutrophilic leukemia (167)

 Chronic eosinophilic leukemia, NOS (166)

 Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)

 Polycythemia vera (PCV) (57)

 Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)

 Myeloproliferative neoplasm (MPN), unclassifiable (60)

 Chronic myelomonocytic leukemia (CMMoL) (54)

 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

 Transformed to AML (70) – Go to signature line.

Laboratory studies at last evaluation prior to the start of the preparative regimen:

528. WBC

 Known – Go to question 529

 Unknown– Go to question 530

529. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

530. Hemoglobin

 Known – Go to question 531

 Unknown – Go to question 533

531. ___ ___ ___ ___ ● ___ ___  g/dL

 g/L

 mmol/L

532. Was RBC transfused < 30 days before date of test?

 Yes

 No

533. Platelets

 Known – Go to question 534

 Unknown – Go to question 536

534. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

535. Were platelets transfused < 7 days before date of test?

 Yes

 No

536. Neutrophils

 Known – Go to question 537

 Unknown – Go to question 538

537. ___ ___%

538. Blasts in bone marrow

 Known – Go to question 539

 Unknown – Go to question 540

539. ___ ___ ___ %

540. Were cytogenetics tested (conventional or FISH)?

 Yes – Go to question 541

 No – Go to question 568

 Unknown – Go to question 568

541. Results of test:

 Abnormalities identified – Go to question 541

 No evaluable metaphases – Go to question 568

 No abnormalities – Go to question 568

Specify cytogenetic abnormalities identified at last evaluation prior to the start of the preparative regimen:

542. Specify number of distinct cytogenetic abnormalities:

 One (1)

 Two (2)

 Three (3)

 Four or more (4 or more)

Monosomy

543. –5

 Yes

 No

544. –7

 Yes

 No

545. –13

 Yes

 No

546. –20

 Yes

 No

547. –Y

 Yes

 No

Trisomy

548. +8

 Yes

 No

549. +19

 Yes

 No

Translocation

550. t(1;3)

 Yes

 No

551. t(2;11)

 Yes

 No

552. t(3;3)

 Yes

 No

553. t(3;21)

 Yes

 No

554. t(6;9)

 Yes

 No

555. t(11;16)

 Yes

 No

Deletion

556. del(3q) / 3q-

 Yes

 No

557. del(5q) / 5q-

 Yes

 No

558. del(7q) / 7q-

 Yes

 No

559. del(9q) / 9q-

 Yes

 No

560. del(11q) / 11q-

 Yes

 No

561. del(12p) / 12p-

 Yes

 No

562. del(13q) / 13q-

 Yes

 No

563. del(20q) / 20q-

 Yes

 No

Inversion

564. inv(3)

 Yes

 No

Other

565. i17q

 Yes

 No

566. Other abnormality

 Yes – Go to question 567

 No – Go to question 568

567. Specify other abnormality:

Status at Transplantation

568. What was the disease status?

 Complete remission (CR) – requires all of the following, maintained for ≥ 4 weeks: * bone marrow evaluation: < 5% myeloblasts with normal maturation of all cell lines * peripheral blood evaluation: hemoglobin ≥ 11 g/dL untransfused and without erythropoietin support; ANC ≥ 1000 / mm 3 without myeloid growth factor support; platlets ≥ 100 x 10 9/L without thrombopoietic support; 0% blasts - Go to question 572

 Hematologic improvement (HI) – requires one measurement of the following, maintained for ≥ 8 weeks without ongoing cytotoxic therapy; specify which cell line was measured to determine HI response: * HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks * HI-P – for pre-treatment platelet count of > 20 x 10 9L, platelet absolute increase of ≥ 30 x 10 9L; for pre-treatment platelet count of < 20 x 10 9L, platelet absolute increase of ≥ 20 x 10 9L and ≥ 100% from pre-treatment level * HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500 / mm3 - Go to question 569

 No response / stable disease (NR/SD) – does not meet the criteria for at least HI, but no evidence of disease progression - Go to question 572

 Progression from hematologic improvement (Prog from HI) – requires at least one of the following, in the absence of another explanation (e.g., infection, bleeding, ongoing chemotherapy, etc.): * ≥ 50% reduction from maximum response levels in granulocytes or platelets * reduction in hemoglobin by ≥ 1.5 g/dL *transfusion dependence - Go to question 570

 Relapse from complete remission (Rel from CR) – requires at least one of the following: * return to pre-treatment bone marrow blast percentage * decrease of ≥ 50% from maximum response levels in granulocytes or platelets * transfusion dependence, or hemoglobin level ≥ 1.5 g/dL lower than prior to therapy - Go to question 571

 Not assessed - Go to signature line

569. Specify the cell line examined to determine HI status:

 HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks - Go to question 572

 HI-P – for pre-treatment platelet count of > 20 x 10 9L, platelet absolute increase of ≥ 30 x 10 9L; for pre-treatment platelet count of < 20 x 10 9L, platelet absolute increase of ≥ 20 x 10 9L and ≥ 100% from pre-treatment level – Go to question 572

 HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500 / mm3 - Go to question 572

570. Date of progression: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 572

YYYY MM DD

571. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 572

YYYY MM DD

572. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to signature line

YYYY MM DD

Other Leukemia (OL)

573. Specify the other leukemia classification:

 Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 575

 Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 575

 Hairy cell leukemia (35) - Go to question 578

 Prolymphocytic leukemia (PLL), NOS (37) - Go to question 575

 PLL, B-cell (73) - Go to question 575

 PLL, T-cell (74) - Go to question 575

 Other leukemia, NOS (30) - Go to question 577

 Other leukemia (39) - Go to question 574

574. Specify other leukemia: – Go to question 577

575. Was any 17p abnormality detected?

 Yes – If disease classification is CLL, go to question 576. If PLL, go to question 578.

 No

576. Did a histologic transformation to diffuse large B-cell lymphoma (Richter syndrome) occur at any time after CLL diagnosis?

 Yes – Go to question 583– Also complete disease classification questions 583-585

 No – Go to question 578

Status at transplantation:

577. What was the disease status? (Atypical CML)

 Primary induction failure – Go to question 579

 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 579

 2nd complete remission – Go to question 579

 ≥ 3rd complete remission – Go to question 579

 1st relapse – Go to question 579

 2nd relapse – Go to question 579

 ≥ 3rd relapse – Go to question 579

 No treatment – Go to question 579

578. What was the disease status? (CLL, PLL, Hairy cell Leukemia)

 Never treated

 Complete remission (CR)

 Nodular partial remission (nPR)

 Partial remission (PR)

 No response / stable (NR / SD)

 Progression

 Relapse (untreated)

579. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Hodgkin Lymphoma

580. Specify Hodgkin lymphoma classification:

 Nodular lymphocyte predominant Hodgkin lymphoma (155)

 Lymphocyte-rich (151)

 Nodular sclerosis (152)

 Mixed cellularity (153)

 Lymphocyte depleted (154)

 Hodgkin lymphoma, NOS (150)

Status at transplantation:

581. What was the disease status?

Disease untreated

PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or progressive disease on treatment.

 PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment.

PIF unk - Primary induction failure – sensitivity unknown

CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant

CR2 - 2^nd complete remission

CR3+ - 3^rd or subsequent complete remission

REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse

REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment

REL1 sen - 1^st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2)

REL1 unk - 1^st relapse – sensitivity unknown

REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse

REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment

REL2 sen - 2^nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)

REL2 unk - 2^nd relapse – sensitivity unknown

REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse

REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment

REL3+ sen - 3^rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)

REL3+ unk - 3^rd relapse or greater – sensitivity unknown

582. Date assessed: ___ ___ ___ ___ - ___ ___ - ___ ___ - Go to signature line

YYYY MM DD

Non-Hodgkin Lymphoma

583. Specify Non-Hodgkin lymphoma classification:

 Splenic marginal zone B-cell lymphoma (124)

 Extranodal marginal zone B-cell lymphoma of mucosal associated lymphoid tissue type (MALT) (122)

 Nodal marginal zone B-cell lymphoma (± monocytoid B-cells) (123)

 Follicular, predominantly small cleaved cell (Grade I follicle center lymphoma) (102)

 Follicular, mixed, small cleaved and large cell (Grade II follicle center lymphoma) (103)

 Follicular, predominantly large cell (Grade IIIA follicle center lymphoma) (162)

 Follicular, predominantly large cell (Grade IIIB follicle center lymphoma) (163)

 Follicular (grade unknown) (104)

 Mantle cell lymphoma (115)

 Intravascular large B-cell lymphoma (136)

 Primary mediastinal (thymic) large B-cell lymphoma (125)

 Primary effusion lymphoma (138)

 Diffuse, large B-cell lymphoma — NOS (107)

 Burkitt lymphoma (111)

 B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma (140)

 B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin Lymphoma (149)

 T-cell / histiocytic rich large B-cell lymphoma (120)

 Primary diffuse large B-cell lymphoma of the CNS (118)

 Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)

 Other B-cell lymphoma (129) – Go to question 584

 Extranodal NK / T-cell lymphoma, nasal type (137)

 Enteropathy-type T-cell lymphoma (133)

 Hepatosplenic T-cell lymphoma (145)

 Subcutaneous panniculitis-like T-cell lymphoma (146)

 Mycosis fungoides (141)

 Sezary syndrome (142)

 Primary cutaneous CD30+ T-cell lymphoproliferative disorders [Primary cutaneous anaplastic large-cell lymphoma (C-ALCL), lymphoid papulosis] (147)

 Peripheral T-cell lymphoma (PTCL), NOS (130)

 Angioimmunoblastic T-cell lymphoma (131)

 Anaplastic large-cell lymphoma (ALCL), ALK positive (143)

 Anaplastic large-cell lymphoma (ALCL), ALK negative (144)

 T-cell large granular lymphocytic leukemia (126)

 Aggressive NK-cell leukemia (27)

 Adult T-cell lymphoma / leukemia (HTLV1 associated) (134)

 Other T-cell / NK-cell lymphoma (139) – Go to question 584

584. Specify other lymphoma:

585. Is the non-Hodgkin lymphoma histology reported at diagnosis (question 583) a transformation from CLL?

 Yes – Go to question 587- Also complete Disease Classification questions 573 - 576

 No - Go to question 586

586. Was histologic transformation (not from CLL) detected at the same time or at any time after the lymphoma diagnosis (question 583)?

 Yes

 No

Status at Transplantation

587. What was the disease status?

Disease untreated

PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or progressive disease on treatment.

 PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment.

PIF unk - Primary induction failure – sensitivity unknown

CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant

CR2 - 2^nd complete remission

CR3+ - 3^rd or subsequent complete remission

REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse

REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment

REL1 sen - 1^st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2)

REL1 unk - 1^st relapse – sensitivity unknown

REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse

REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment

REL2 sen - 2^nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)

REL2 unk - 2^nd relapse – sensitivity unknown

REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse

REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment

REL3+ sen - 3^rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)

REL3+ unk - 3^rd relapse or greater – sensitivity unknown

588. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Multiple Myeloma / Plasma Cell Disorder (PCD)

589. Specify the multiple myeloma/plasma cell disorder (PCD) classification:

 Multiple myeloma-lgG (181) - Go to questions 591

 Multiple myeloma-lgA (182) - Go to questions 591

 Multiple myeloma-lgD (183) - Go to questions 591

 Multiple myeloma-lgE (184) - Go to questions 591

 Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185) - Go to questions 591

 Multiple myeloma-light chain only (186) - Go to questions 591

 Multiple myeloma-non-secretory (187) - Go to questions 591

 Plasma cell leukemia (172) - Go to question 597

 Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 597

 Amyloidosis (174) - Go to question 597

 Osteosclerotic myeloma / POEMS syndrome (176) - Go to questions 597

 Light chain deposition disease (177) - Go to questions 597

 Other plasma cell disorder (179) - Go to question 590

590. Specify other plasma cell disorder: - Go to question 597

591. Light chain

 κ (kappa)

 λ (lambda)

592. What was the Durie-Salmon staging (at diagnosis)?

 Stage I (All of the following: Hgb > 10g/dL; serum calcium normal or <10.5 mg/dL; bone x-ray normal bone structure (scale 0), or solitary bone plasmacytoma only; low M-component production rates IgG < 5g/dL, IgA < 3g/dL; urine light chain M-component on electrophoresis <4g/24h) – Go to questions 593

 Stage II (Fitting neither Stage I or Stage III) – Go to questions 593

 Stage III (One of more of the following: Hgb < 8.5 g/dL; serum calcium > 12 mg/dL; advanced lytic bone lesions (scale 3); high M-component production rates IgG >7g/dL, IgA > 5g/dL; Bence Jones protein >12g/24h) – Go to questions 593

 Unknown – Go to questions 594

593. What was the Durie-Salmon sub classification (at diagnosis)?

 A - relatively normal renal function (serum creatinine < 2.0 mg/dL)

 B - abnormal renal function (serum creatinine ≥ 2.0 mg/dL)

I.S.S.:

594. Serum β2-microglobulin: ___ ___ ___ ● ___ ___ ___  μg/dL

 mg/L

 nmol/L

595. Serum albumin: ___ ___ ● ___  g/dL

 g/L

596. Stage

 1 (β₂-mic < 3.5, S. albumin > 3.5)

 2 (β₂-mic 3.5–< 5.5, S. albumin —)

 3 (β₂-mic ≥ 5.5; S. albumin —)

597. Were cytogenetics tested (conventional or FISH)?

Yes – Go to questions 598

No – Go to question 619

Unknown – Go to question 619

598. Results of test:

Abnormalities identified – Go to question 599

No evaluable metaphases – Go to question 619

No abnormalities – Go to question 619

Specify cytogenetic abnormalities identified at any time prior to the start of the preparative regimen:

Trisomy

599. +3

Yes

No

600. +5

Yes

No

601. +7

Yes

No

602. +9

Yes

No

603. +11

Yes

No

604. +15

Yes

No

605. +19

Yes

No

Translocation

606. t(4;14)

Yes

No

607. t(6;14)

Yes

No

608. t(11;14)

Yes

No

609. t(14;16)

Yes

No

610. t(14;20)

Yes

No

Deletion

611. del 13/13q-

Yes

No

612. del 17/17p-

Yes

No

Other

613. Hyperdiploid (>50)

Yes

No

614. Hypodiploid (<46)

Yes

No

615. Any abnormality at 1q

Yes

No

616. Any abnormality at 1p

Yes

No

617. Other abnormality

Yes – Go to question 618

No – Go to question 619

618. Specify other abnormality:______________________________________________

Status at transplantation:

619. What was the disease status?

 Stringent complete remission (sCR). - CR as defined, plus: normal free light chain ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence (confirmation with repeat bone marrow biopsy not needed). (Presence and/or absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by immunohistochemistry and/or immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting the presence of an abnormal clone is κ/λ of > 4:1 or < 1:2.) sCR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy sCR requirements.

 Complete remission (CR) — negative immunofixation on serum and urine samples, and disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in the bone marrow (confirmation with repeat bone marrow biopsy not needed). CR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy CR requirements.

 Near complete remission (nCR) — serum & urine M-protein detectable by immunoelectrophoresis (IFE), but not on electrophoresis (negative SPEP & UPEP); ≤ 5% plasma cells in bone marrow. nCR requires two consecutive assessments made at any time before the initiation of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy nCR requirements.

 Very good partial remission (VGPR ) — serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours. VGPR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy VGPR requirements.

 Partial remission (PR) — ≥ 50% reduction in serum M-protein, and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If the serum and urine M-protein are unmeasurable (i.e., do not meet any of the following criteria: • serum M-protein ≥ 1 g/dL. Urine M-protein ≥ 200 mg/24 hours • serum free light chain assay shows involved level ≥ 10 mg/dL, provided serum free light chain ratio is abnormal), a ≥ 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a ≥ 50% reduction in plasma cells is required in place of M-protein, provided the baseline bone marrow plasma cell percentage was ≥ 30%. In addition to the above listed criteria, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. PR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy PR requirements.

 Stable disease (SD) — not meeting the criteria for CR, VGPR, PR or PD. SD requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy SD requirements.

 Progressive disease (PD) — requires any one or more of the following: Increase of ≥ 25% from baseline in: serum M-component and/or (absolute increase ≥ 0.5 g/dL) (for progressive disease, serum M-component increases of ≥ 1 g/dL are sufficient to define relapse if the starting M-component is ≥ 5 g/dL). Urine M-component and/or (absolute increase ≥ 200 mg.24 hours) for recipients without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase > 10 mg/dL). Bone marrow plasma cell percentage (absolute percentage ≥ 10%) (relapse from CR has a 5% cutoff vs. 10% for other categories of relapse) definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in the size of any existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol) that can be attributed solely to the plasma cell proliferative disorder PD requires two consecutive assessments made at any time before classification as disease progression, and/or the institution of any new therapy

 Relapse from CR (Rel) (untreated) — requires one or more of the following: reappearance of serum or urine M-protein by immunofixation or electrophoresis development of ≥ 5% plasma cells in the bone marrow (relapse from CR has a 5% cutoff vs. 10% for other categories of relapse) appearance of any other sign of progression (e.g., new plasmacytoma, lytic bone lesion, hypercalcemia) Rel requires two consecutive assessments made at any time before classification as relapse, and/or the institution of any new therapy.

 Unknown

 Not applicable (Amyloidosis with no evidence of myeloma)

620. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Solid Tumors

621. Specify the solid tumor classification:

Breast cancer (250)

Lung, small cell (202)

 Lung, non-small cell (203)

 Lung, not otherwise specified (230)

 Germ cell tumor, extragonadal (225)

 Testicular (210)

 Ovarian (epithelial) (214)

 Bone sarcoma (excluding Ewing family tumors) (273)

 Ewing family tumors of bone (including PNET) (275)

 Ewing family tumors, extraosseous (including PNET) (276)

 Fibrosarcoma (244)

 Hemangiosarcoma (246)

 Leiomyosarcoma (242)

 Liposarcoma (243)

 Lymphangio sarcoma (247)

 Neurogenic sarcoma (248)

 Rhabdomyosarcoma (232)

 Synovial sarcoma (245)

 Soft tissue sarcoma (excluding Ewing family tumors) (274)

 Central nervous system tumor, including CNS PNET (220)

 Medulloblastoma (226)

 Neuroblastoma (222)

 Head / neck (201)

 Mediastinal neoplasm (204)

 Colorectal (228)

 Gastric (229)

 Pancreatic (206)

 Hepatobiliary (207)

 Prostate (209)

 External genitalia (211)

 Cervical (212)

 Uterine (213)

 Vaginal (215)

 Melanoma (219)

 Wilm tumor (221)

 Retinoblastoma (223)

 Thymoma (231)

 Renal cell (208)

 Other solid tumor (269)

 Solid tumor, not otherwise specified (200)

- Go to signature line

Severe Aplastic Anemia

622. Specify the severe aplastic anemia classification:

 Acquired severe aplastic anemia, not otherwise specified (301)

 Acquired SAA secondary to hepatitis (302)

 Acquired SAA secondary to toxin / other drug (303)

 Acquired amegakaryocytosis (not congenital) (304)

 Acquired pure red cell aplasia (not congenital) (306)

 Other acquired cytopenic syndrome (309)

- Go to signature line

Inherited Abnormalities of Erythrocyte Differentiation or Function

623. Specify the inherited abnormalities of erythrocyte differentiation or function classification:

 Paroxysmal nocturnal hemoglobinuria (PNH) (56)

 Shwachman-Diamond (305)

 Diamond-Blackfan anemia (pure red cell aplasia) (312)

 Other constitutional anemia (319)

 Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease).

 Sickle thalassemia (355)

 Sickle cell disease (356)

 Thalassemia, not otherwise specified (350)

 Other hemoglobinopathy (359)

- Go to signature line

Disorders of the immune system

624. Specify disorder of immune system classification:

 Adenosine deaminase (ADA) deficiency / severe combined immunodefiency (SCID) (401)

 Absence of T and B cells SCID (402)

 Absence of T, normal B cell SCID (403)

 Omenn syndrome (404)

 Reticular dysgenesis (405)

 Bare lymphocyte syndrome (406)

 Other SCID (419)

 SCID, not otherwise specified (410)

 Ataxia telangiectasia (451)

 HIV infection (452)

 DiGeorge anomaly (454)

 Common variable immunodeficiency (457)

 Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459)

 Kostmann agranulocytosis (congenital neutropenia) (460)

 Neutrophil actin deficiency (461)

 Cartilage-hair hypoplasia (462)

 CD40 ligand deficiency (464)

 Other immunodeficiencies (479)

 Immune deficiency, not otherwise specified (400)

 Chediak-Higashi syndrome (456)

 Griscelli syndrome type 2 (465)

 Hermansky-Pudlak syndrome type 2 (466)

 Chronic granulomatous disease (455)

 Wiskott-Aldrich syndrome (453)

 X-linked lymphoproliferative syndrome (458)

- Go to signature line

Inherited abnormalities of platelets

625. Specify inherited abnormalities of platelets classification:

 Congenital amegakaryocytosis / congenital thrombocytopenia (501)

 Glanzmann thrombasthenia (502)

 Other inherited platelet abnormality (509)

- Go to signature line

Inherited Disorders of Metabolism

626. Specify inherited disorders of metabolism classification:

 Osteopetrosis (malignant infantile osteopetrosis) (521)

Leukodystrophies

 Metachromatic leukodystrophy (MLD) (542)

 Adrenoleukodystrophy (ALD) (543)

 Krabbe disease (globoid leukodystrophy) (544)

 Lesch-Nyhan (HGPRT deficiency) (522)

 Neuronal ceroid lipofuscinosis (Batten disease) (523)

Mucopolysaccharidoses

 Hurler syndrome (IH) (531)

 Scheie syndrome (IS) (532)

 Hunter syndrome (II) (533)

 Sanfilippo (III) (534)

 Morquio (IV) (535)

 Maroteaux-Lamy (VI) (536)

 β-glucuronidase deficiency (VII) (537)

 Mucopolysaccharidosis (V) (538)

 Mucopolysaccharidosis, not otherwise specified (530)

Mucolipidoses

 Gaucher disease (541)

 Niemann-Pick disease (545)

 I-cell disease (546)

 Wolman disease (547)

 Glucose storage disease (548)

 Mucolipidoses, not otherwise specified (540)

Polysaccharide hydrolase abnormalities

 Aspartyl glucosaminidase (561)

 Fucosidosis (562)

 Mannosidosis (563)

 Polysaccharide hydrolase abnormality, not otherwise specified (560)

 Other inherited metabolic disorder (529)

 Inherited metabolic disorder, not otherwise specified (520)

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Histiocytic disorders

627. Specify histiocytic disorder classification:

 Hemophagocytic lymphohistiocytosis (HLH) (571)

 Langerhans cell histiocytosis (histiocytosis-X) (572)

 Hemophagocytosis (reactive or viral associated) (573)

 Malignant histiocytosis (574)

 Other histiocytic disorder (579)

 Histiocytic disorder, not otherwise specified (570)

- Go to signature line

Autoimmune diseases

628. Specify autoimmune disease classification:

Arthritis

 Rheumatoid arthritis (603)

 Psoriatic arthritis / psoriasis (604)

 Juvenile idiopathic arthritis (JIA): systemic (Stills disease) (640)

 JIA: oligoarticular (641)

 JIA: polyarticular (642)

 JIA: other (643)

 Other arthritis (633)

Multiple sclerosis

 Multiple sclerosis (602)

Connective tissue diseases

 Systemic sclerosis (scleroderma) (607)

 Systemic lupus erythematosis (SLE) (605)

 Sjögren syndrome (608)

 Polymyositis / dermatomyositis (606)

 Antiphospholipid syndrome (614)

 Other connective tissue disease (634)

Vasculitis

 Wegener granulomatosis (610)

 Classical polyarteritis nodosa (631)

 Microscopic polyarteritis nodosa (632)

 Churg-Strauss (635)

 Giant cell arteritis (636)

 Takayasu (637)

 Behcet syndrome (638)

 Overlap necrotizing arteritis (639)

 Other vasculitis (611)

Other neurological autoimmune diseases

 Myasthenia gravis (601)

 Other autoimmune neurological disorder (644)

Hematological autoimmune diseases

 Idiopathic thrombocytopenic purpura (ITP) (645)

 Hemolytic anemia (646)

 Evan syndrome (647)

 Other autoimmune cytopenia (648)

Bowel diseases

 Crohn’s disease (649)

 Ulcerative colitis (650)

 Other autoimmune bowel disorder (651)

- Go to signature line

Other Disease

629. Specify other disease: _________________________________________

First Name: ____________________________________________________________________________

Last Name:

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2400 revision 4 (page 1 of 86) June 2009 FINAL 12/13/2012

Internal use: Document number F00485 revision 2 Replaces: F00485 version 1.0 July 2007