Blood and Marrow Transplant Program One Medical Center Dr. Lebanon, NH Phone: (603) Fax: (603)

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1 Blood and Marrow Transplant Program One Medical Center Dr. Lebanon, NH Phone: (603) Fax: (603) ROUNDTABLE DISCUSSION BEST PRACTICES AT A SMALL TRANSPLANT CENTER Friday, February 18, 2011 Dorie Belloni, BS Dartmouth Hitchcock Medical Center Lebanon, NH dorothy.r.belloni@hitchcock.org This will be a very informal session in which data managers from small centers share experiences, challenges, practices and ideas. Small centers face different challenges than larger, for example there are generally only one or two data managers tasked with completing all aspects of CIBMTR reporting. This person usually has additional responsibilities. Prioritization and organization are essential. Ideally, this dialogue will allow us to pick and choose the methods others are using to improve efficiency at our own sites. Below is a rough outline of how we will proceed. 1. Introductions a. Name, program, approximate # transplants/physicians, etc. b. Years in job c. Background medical, information technology, etc. 2. Current process for data collection and entry a. Scope of responsibility just CIBMTR reporting, CIBMTR and in-house database, any other responsibilities b. Data back to centers and AGNIS 3. Process for backlog a. Keeping motivation when there is so much to do!! How not to be overwhelmed. 4. Organization Aids a. Challenges of finding info in medical record, esp for no medical background. b. Outlook/Calendar ticklers 5. Information gathering aids (I pilfered these from presentations at previous meetings. All are on the CIBMTR website.) a. Pre-transplant form with all info for Pre-ted on it to be filled out with MDs, APRNs and RNs. (Denise Bellman, Cincinnati Children's Hospital Medical Center, 2008 Clinical Research Professionals / Data Management Conference) b. Comorbidity worksheet (Kim Phillips, DFCI, 2010 Clinical Research Professionals/Data Management Conference) c. GVHD worksheets (Kim Phillips, DFCI, 2010 Clinical Research Professionals/Data Management Conference; Roby Nicklow, University of

2 Minnesota and Erin Richardson, CancerCare Manitoba, Agenda: 2009 Clinical Research Professionals/Data Management Conference; Denise Bellman, Cincinnati Children's Hospital Medical Center, 2008 Clinical Research Professionals / Data Management Conference) d. Long-term follow-up (Denise Bellman, Cincinnati Children's Hospital Medical Center, 2008 Clinical Research Professionals / Data Management Conference) e. Disease status (Denise Bellman, Cincinnati Children's Hospital Medical Center, 2008 Clinical Research Professionals / Data Management Conference) 6. Other responsibilities a. RFIs b. Regulatory issues c. QA/QI reporting d. Data for center based research projects/clinical trials 7. Conclusion and Summary a. Please give me your if would like a copy of summary notes b. Maybe form support team/group for small centers

3 Blood and Marrow Transplant Patient Information Sheet Patient Name MR# DOB Diagnosis Wt. (kg) Ht. (cm) M2 Ethnicity: Sex: UPN # 0.00 BMT Attending: Name Allergies: BMT Coordinator: Name Donor Information: HLA: / 6 ( / 8 ) Type of Transplant MR/ID# Wt. Ablative Non-Ablative Reduced Intensity DOB/Age Sex GVHD Prophylaxis: Stem Cell Processing: None CSP/Pred ATG MTX CSP CSP/MTX T-cell depletion Stem Cell Source: Auto Syngeneic Testicular Irradiation: Yes No Related Un-Related Cranial Irradiation: Yes No Intrathecal Medication: Yes No Relationship: Treatment and Studies: Date Signed Stem Cell Product Type: Cord Blood PBSC Marrow Other Cell Dose: Back-up: Date of Harvest: Diagnosis Information: BMT Treatment Summary: Stage: Grade: Day Date Treatment Dose Primary Site: Metastatic Sites: Date of Diagnosis: Relapse Dates: Current Disease Status: Prior Research Studies: Prior Radiation: Prior Chemo: Prior BMT: Other Therapy: Total anthracycline/m2: Other Medical History: Current L/K Score: Significant coexisting diseases: Transfusion and Premed Information: Pre-Med Blood Products Yes No Benadryl mg Tylenol mg Other BMT Attending Signature: BMT Coordinator Signature: Date: Date: Page 1

4 Blood and Marrow Transplant Patient Information Sheet Evaluation Results: Patient MR# Name Referral Information: LAB ABO/Rh CMV HSV PATIENT DATE DONOR DATE Referring Institution Referring Physician RMD Address HepB surface Ag HepB Core AB HepA IgM/IgG HIV NAT or HIV p24 ag HTLV (1 & 2) HepC AB (virus) RMD Phone Number RMD Fax Number RMD Private Physician PMD Address EBV VZV Syphilis Toxo IgG Orsa VRE Creatinine/BUN T. bili SGOT/SGPT PMD Phone PMD Fax PMD Rad/Onc Nutrition Psych/SocialWorker Dental Surgeon ENT Physician B-HCG Anti A/B titer Patient/Family Information: Evaluation Results Date Parents Cr. Clearance/GFR /1.73 sq.m2 Parents' Address MUGA or echo EKG Parents' Phone PFT's / O2 sat Work Phone: BM bx & asp Parent's Lumbar Puncture Marital Status Scans: Occupation Other Patient Lab Values Lab Value Date Venous Access Double Lumen CVC Coments: Mediport Single lumen CVC Double Lumen Apheresis CVC I have personally reviewed all evaluations and at this time the Patient and donor are acceptable to proceed with the proposed transplant procedure. BMT Attending Signature: Date: BMT Coordinator Signature: Date:

5 Patient Name MR# BMT MD: Name BMT Coordinator: Home Phone: Cell Phone: Home Care: Pharmacy: BMT Summary and Plan: Name Follow up: Weekly Monthly Every 3 months BMT Long Term follow-up Date 6 Mo BMT F/U 9 Mo BMT F/U Disease evaluation (Scans, labs etc) 1 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Disease evaluation (Scans, labs etc) 18 Months BMT F/U 2 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Disease evaluation (Scans, labs etc) 2 yr 6 mo BMT F/U 3 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Other 4 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Other 5 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Other 6 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Other 7 Yr BMT F/U Immunizations PFT Endocrine ECHO Audiogram Ophthalmology Other BMT F/U labs should include CBC w/diff, Renal and Liver panel, Ca. Mg and Phos

6 Name of Patient: Medical Record: Date: Visit: up to Day month year ACUTE GVHD Has patient developed acute GVHD for the first time or a severe flare since last visits or post Day 100? NO YES Date of Onset: Diagnosis based on : Histologic Evidence Site Date of Biopsy Clinical Evidence Overall severity of acute GVHD since last contact: Maximum overall grade: I II III IV Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 Degree of Certainty maculopapular generalized general erythrodema rash<25% rash 25-50% erythrodema with bullous formation SKIN No Rash maculopapular GI LIVER No Diarrhea billrubin (<2 mg/dl) Diarrhea ( ml/m 2 Diarrhea ( ml/m 2 ) billrubin ( mg/dl) billrubin ( mg/dl) Diarrhea (>833 ml/m 2 ) billrubin ( mg/dl) Severe abdominal pain, with or without ileus billrubin (>15 mg/dl) Does patient still have symptoms of AGHVD: Yes No. Specific therapy used to treat AGVHD: Please indicate whether meds were started or continued at prophylactic level Is patient still taking immunosuppressive agents to treat or prevent GVHD? Yes No Date stopped Mo/Year Please rate the overall Lansky/Karnofsky Scale of the patient since last contact: Lansky Scale (10-100) for <16 years old Karnofsky Scale (10-100) for > 16 years old Select the phrase in the Lansky-Play-Performance Scale Select the phrase in the Karnofsky Scale which best describes which best describes the activity status of the patient. the activity status of the patient. Normal range 100 Fully active 90 Minor restriction in physically strenuous play 80 Restricted in strenuous play, tires more easily, otherwise active Mild to moderate restrictions 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 for any active play; fully able to engage in quite play Moderate to severe restriction 40 Able to initiate quite activities 30 Needs considerable assistance for quit activities 20 Limited to very passive activity initiated by others (eg: TV) 10 Completely disabled, not even passive play Able to carry on normal activity; no special care is needed 100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work; able to live at home, care for most personal needs; a varying amount of assistance is needed 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly. 40 Disabled; requires special care and assistance 30 Severely disabled; hospitalization indicated, although death not imminent 20 Very sick; hospitalization necessary 10 Moribund; fatal process progressing rapid SIGNATURE

7 Name of Patient: Medical Record: Date: Visit: months year CHRONIC GVHD Has patient developed clinical chronic GVHD since last visits? NO YES Date of Onset: Did this progress from Acute GVHD? Yes Diagnosis based on : Histologic Evidence Site Date of Biopsy Clinical Evidence Overall severity of chronic GVHD since last contact: mild signs and symptoms of chronic GVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy (steroids and/or cyclosporine FK 506) moderate-signs and symptoms of chronic GVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy defined as steroids and/or cyclosporine or FK 506 severe signs and symptoms of chronic GVHD limit function substantially despite appropriate therapy or are progressive through second line therapy Maximum grade of chronic GVHD limited extensive Does patient still have symptoms of CGHVD: Yes No. Please check if there was organ involvement with CGVHD from list below: Skin involvement (BSA % ) Eyes Contractures Lung involvement Oral involvement Arthritis Weight Loss Thrombocytopenia Esophageal Involvement Chronic diarrhea Malabsorption Abnormal pain/cramps Chronic nausea/vomiting Myositis Myasthenia Other, specify Specific therapy used to treat CGVHD: Please indicate whether meds were started or continued at prophylactic level Is patient still taking immunosuppressive agents to treat or prevent GVHD? Yes No Date stopped Mo/Year Please rate the overall Lansky/Karnofsky Scale of the patient since last contact: Lansky Scale (10-100) for <16 years old Karnofsky Scale (10-100) for > 16 years old Select the phrase in the Lansky-Play-Performance Scale Select the phrase in the Karnofsky Scale which best describes which best describes the activity status of the patient. the activity status of the patient. Normal range 100 Fully active 90 Minor restriction in physically strenuous play 80 Restricted in strenuous play, tires more easily, otherwise active Mild to moderate restrictions 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 for any active play; fully able to engage in quite play Moderate to severe restriction 40 Able to initiate quite activities 30 Needs considerable assistance for quit activities 20 Limited to very passive activity initiated by others (eg: TV) 10 Completely disabled, not even passive play Able to carry on normal activity; no special care is needed 100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work; able to live at home, care for most personal needs; a varying amount of assistance is needed 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly. 40 Disabled; requires special care and assistance 30 Severely disabled; hospitalization indicated, although death not imminent 20 Very sick; hospitalization necessary 10 Moribund; fatal process progressing rapid SIGNATURE

8 Lansky Scale (10-100) for <16 years old Select the phrase in the Lansky-Play-Performance Scale which best describes the activity status of the patient. Normal range 100 Fully active 90 Minor restriction in physically strenuous play 80 Restricted in strenuous play, tires more easily, otherwise active Mild to moderate restrictions 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 for any active play; fully able to engage in quite play Moderate to severe restriction 40 Able to initiate quite activities 30 Needs considerable assistance for quit activities 20 Limited to very passive activity initiated by others (eg: TV) 10 Completely disabled, not even passive play Karnofsky Scale (10-100) for > 16 years old Select the phrase in the Karnofsky Scale which best describes the activity status of the patient. Able to carry on normal activity; no special care is needed 100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work; able to live at home, care for most personal needs; a varying amount of assistance is needed 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly. 40 Disabled; requires special care and assistance 30 Severely disabled; hospitalization indicated, although death not imminent 20 Very sick; hospitalization necessary 10 Moribund; fatal process progressing rapid

9 44 Binney Street Boston, MA Pre-Transplant Co-Morbidity Evaluation Form Patient Identification Were there clinically significant co-existing disease or organ impairment at time of patient assessment prior to preparative regimen? Yes No (Check all that apply:) Yes No Not Done Comorbidity Definitions Arrhythmia Atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmias Cardiac Coronary artery disease, congestive heart failure, myocardial infarction, or EF 50% Cerebrovascular disease Transient ischemic attack or cerebrovascular accident Diabetes Requiring treatment with insulin or oral hypoglycemics but not diet alone Heart valve disease Except mitral valve prolapse Hepatic, mild Chronic hepatitis, bilirubin > ULN to 1.5 x ULN, or AST/ALT > ULN x 2.5 x ULN Hepatic, moderate/severe Liver cirrhosis, bilirubin > 1.5 x ULN, or AST/ALT > 2.5 x ULN Infection Requiring continuation of antimicrobial treatment after day O Inflammatory bowel disease Crohn disease or ulcerative colitis Obesity Patients with body mass index > 35 kg/m2 Peptic ulcer Requiring treatment Psychiatric disturbance Depression or anxiety requiring psychiatric consult or treatment Pulmonary, moderate DLco and/or FEV % or dyspnea on slight activity Pulmonary, severe DLco and/or FEV 1 65% or dyspnea at rest or requiring oxygen Renal, moderate/severe Serum creatinine > 2 mg/dl or > 177 μmol/l, on dialysis, or prior renal transplant Rheumatologic SLE, RA, polymyositis, mixed CTD, or polymyalgia Solid tumor, prior Treated at any time point in patient s past medical history, excluding nonmelanoma skin cancer Other Specify: Physician s Name [print] Physician Signature Date One or more vessel-coronary artery stenosis requiring medical treatment, stent or bypass graft. EF indicates ejection fraction; ULN, upper limit of normal; SLE, systemic lupus erythematosus; RA, rheumatoid arthritis; CTD connective tissue disease; DLco, diffuse capacity of carbon monoxide.

10 Clinical GVHD Assessment Date: 9/3/2010 Patient Name: BWH # Protocol or Tx Plan #: Karnofsky: Check here if patient experienced severe lung dysfunction* (*Requiring oxygen support, bronchoscopy, or intubation) Code Differential Diagnosis GVHD Drug Rxn Cond Reg TPN Infect VOD Other Skin % body rash: Lower GI Vol: Upper GI Liver Max bili: Chronic GVHD: Limited Extensive Organ Involvement: Treatment: CSA Tacrolimus Pred Methylpred Ontak Pentostatin MMF Etanercept Other Sirolimus Code Definitions: Skin: 0 No rash 1 Maculopapular rash, <25% of body surface 2 Maculopapular rash, 25-50% of body surface 3 Generalized erythroderma 4 Generalized erythroderma with bullous formation and desquamation Lower GI (Diarrhea): 0 None 1 <500 ml/day or <280 ml/m ml/day or ml/m ml/day or ml/m 2 4 >1500 ml/day or >833 ml/m 2 5 Severe abdominal pain with or without ileus, or stool with frank blood or melena Upper GI: 0 No protracted nausea and vomiting 1 Persistent nausea, vomiting or anorexia Liver (Bilirubin): 0 <2.0 mg/dl mg/dl mg/dl mg/dl 4 >15.1 mg/dl Signature

11 University of Minnesota Medical Center, Fairview PHYSICIAN PROGRESS NOTES Patient Identification Plate agvhd Assessment PEDIATRIC in Past 7 Days from to CHECK ONE : No Acute GVHD to Date History of Acute GVHD with no current Flare Acute GVHD progressed to Chronic (Complete Chronic GVHD Forms-baseline) Active Acute GVHD (complete Clinical GVHD Assessment below) Clinical GVHD Assessment Highest Stage in Past 7 Days from to Lansky Score Organ: CLINICAL Stage: Biopsy: (circle GVHD involved organ) (if done in past 7 days) Equ Skin % rash: Lower GI [<25%] [26-50] [>50%] [bullous / Desquamation] vol: /m² <280ml/m² ( 281- ( 556- (>834ml) [severe abd pain w/ or w/o 555ml/m²) 833ml/m²) frank blood or ileus Differential Diagnosis: (MUST complete if other organ etiology occurring) Drug Infect TPN VOD Other Liver max bili: Upper GI [2.1 - [3.1 - [6.1 - [>15.1] 3.] 6] 15) [Persistent nausea / vomiting / anorexia] Current Treatment of acute GVHD CSA prophy MMF Pred/MPred TCM/HCT ATG Sirolimus MPred Boluses Tacrolimus Study Drug Other Signature 4/3//2008 PEDS LOWER GI HT 0 ( <280ml/m² ) WT 1 ( ml/m² ) BSA m² 2 ( ml/m² ) 3 ( >834ml/m² )

12 Acute GVHD Assessment Form CLINICAL ACUTE GVHD ASSESSMENT DATE: DAY+ WEEK OF ASSESSMENT: KPS/LPS: Code Differential Diagnosis Drug Cond 0 0 0(GI) GVHD Rxn Reg TPN Infect VOD Other Skin % body rash: Lower GI vol: Upper GI Liver max bill: Code Definitions: Skin: Lower GI (Diarrhea): Upper GI: Liver (Total Bilirubin): 0 No rash 0 No diarrhea 0 No persistent 0 < 34 umol/l 1 Maculopapular rash, 0(GI) Diarrhea < 500 ml/day or < 280 ml/m 2 /day nausea or vomiting umol/l <25% of body surface 1 Diarrhea > 500 but < 1000 ml /day or ml/m 2 /day 1 Persistent nausea, umol/l 2 Maculopapular rash, 2 Diarrhea > 1000 but < 1500 ml/day or ml/m 2 /day or vomiting umol/l 25-50% of body surface 3 Diarrhea > 1500 ml/day or > 833 ml/m 2 /day 4 > 256 umol/l 3 Generalized erythroderma 4 Severe abdominal pain, with or without ileus 4 Generalized erythroderma (use ml/day for adult recipients and ml/m 2 /day for pediatric recipients) with bullous formation and desquamation Physician Signature DMF December, 2008

13 Patient: UPN #: MR #: BMT Date: Timepoint: (Check ONE) Pre-Transplant Day Months Post-BMT Yearly Follow-Up years pbmt Multiple Myeloma / Plasma Cell Leukemia Disease Status Evaluation Indicate the patient s disease status of multiple myeloma or plasma cell leukemia at the specified time point. (see disease status definitions on reverse side) Never Treated Assessment Date: scr Stringent Complete Response Response Number: 1st 2nd CR Complete Response 3 rd or higher VGPR Very Good Partial Response PR Partial Response SD Stable Disease PD Progressive Disease Rel Relapse from CR (untreated) Unk Unknown Disease Status Functional Status of Patient: Post-Transplant Only: No Post-Transplant Relapse/Progression OR Relapse or Progression after Transplant Date of Relapse Relapse Previously Reported Karnofsky Scale (age >16 yrs) Select the phrase in the Karnofsky Scale which best describes the activity status of the patient Able to carry on normal activity; no special care is needed 100 Normal, no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work;, able to live at home and care for most personal needs, a Varying amount of assistance is needed. 70 Cares for self; unable to carry on normal activity or do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; Disease may be progressing rapidly. 40 Disabled, requires special care 30 Severely disabled 20 Hospitalization necessary 10 Fatal process progressing Signature of BMT Physician: Date: Revised 3/08

14 Disease Response Codes Multiple Myeloma: Page 2 scr Stringent Complete Response CR, as defined below, 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 free light chain ratio. An abnormal 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 > 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. CR Complete Response 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. VGPR Very Good Partial Response 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. PR Partial Response > 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 > 10mg/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 chain 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. SD Stable Disease 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. PD Progressive Disease 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 PD, serum M-component increases of > 1g/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 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 PD requirements Rel Relapse from CR 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

15 Patient: UPN #: MR #: BMT Date: Timepoint: (Check ONE) Pre-Transplant Day Months Post-BMT Yearly Follow-Up years pbmt Acute Myelogenous Leukemia Disease Status Evaluation Indicate the patient s disease status of acute myelogenous leukemia at the specified time point. No Treatment for AML Primary induction failure 1st Complete Remission (no previous marrow or extramedullary relapse) 2nd Complete Remission 3rd Complete Remission 4th or greater Complete Remission Assessment Date: If in Remission, Status of Remission: In Cytogenic Remission? Yes No Unk In Molecular Remission? Yes No Unk If in Relapse, Sites of Relapse: 1st Relapse Bone marrow Molecular test results 2nd Relapse Cytogenetic/FISH test results 3rd or greater Relapse CNS Other site Unk Unknown Disease Status Post-Transplant Only: No Post-Transplant Relapse or Progression Functional Status of Patient: OR Relapse or Progression after Transplant Date of Relapse Relapse Previously Reported Karnofsky Scale (age >16 yrs) Select the phrase in the Karnofsky Scale which best describes the activity status of the patient Able to carry on normal activity; no special care is needed 100 Normal, no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work;, able to live at home and care for most personal needs, a Varying amount of assistance is needed. 70 Cares for self; unable to carry on normal activity or do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; Disease may be progressing rapidly. 40 Disabled, requires special care 30 Severely disabled 20 Hospitalization necessary 10 Fatal process progressing Signature of BMT Physician: Date: Revised 3/08

16 Patient: UPN #: MR #: BMT Date: Timepoint: (Check ONE) Pre-Transplant Day Months Post-BMT Yearly Follow-Up years pbmt Lymphoma Hodgkin and Non-Hodgkin Lymphoma Disease Status Evaluation Indicate the patient s disease status of lymphoma at the specified time point (see disease status definitions on reverse side) Pre-Transplant Disease Status: Untreated PIF res Primary induction failure resistant PIF sen / PR1 Primary induction failure sensitive PIF unk Primary induction failure sensitivity unk CR1 1 st Complete Remission CR2 2 nd Complete Remission CR3+ 3 rd or greater Complete Remission CRU1 1 st Complete Remission - Undetermined CRU2 2 nd Complete Remission Undetermined CRU3+ 3 rd or greater CR - Undetermined Unk Unknown Disease Status Post-Transplant Disease Status: CCR Continued Complete Remission CR Complete Remission CRU Complete Remission, Undetermined PR Partial Remission NR / SD No Response / Stable Disease Rel / PD Relapse / Progressive Disease Functional Status of Patient: Karnofsky Scale (age >16 yrs) Select the phrase in the Karnofsky Scale which best describes the activity status of the patient Able to carry on normal activity; no special care is needed 100 Normal, no complaints; no evidence of disease 90 Able to carry on normal activity 80 Normal activity with effort Unable to work;, able to live at home and care for most personal needs, a Varying amount of assistance is needed. 70 Cares for self; unable to carry on normal activity or do active work 60 Requires occasional assistance but is able to care for most needs 50 Requires considerable assistance and frequent medical care Unable to care for self; requires equivalent of institutional or hospital care; Disease may be progressing rapidly. 40 Disabled, requires special care 30 Severely disabled 20 Hospitalization necessary 10 Fatal process progressing Assessment Date: Rel 1 unt 1 st Relapse, Untreated Rel 1 res 1 st Relapse, Resistant Rel 1 sen 1 st Relapse, Sensitive Rel 1 unk 1 st Relapse, Sensitivity Unknown Rel 2 unt 2 nd Relapse, Untreated Rel 2 res 2 nd Relapse, Resistant Rel 2 sen 2 nd Relapse, Sensitive Rel 2 unk 2 nd Relapse, Sensitivity Unknown Rel 3 unt 3 rd or greater Relapse, Untreated Rel 3 res 3 rd or greater Relapse, Resistant Rel 3 sen 3 rd or greater Relapse, Sensitive Rel 3 unk 3 rd or greater Relapse, Sensitivity Unk No Post-Transplant Relapse or Progression OR Relapse or Progression after Transplant Date of Relapse Relapse Previously Reported Signature of BMT Physician: Date: Revised 3/08

17 Page 2 Pre-Transplant Disease Status Hodgkin and Non-Hodgkin Lymphoma: 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 COMPLTE 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 CR rd or Subsequent Remission CRU1-1 st Complete Remission Undetermined: as CR1 above with the exception of persistent scan abnormalities of unknown significance CRU2-2 nd Complete Remission Undetermined CRU rd or Subsequent Complete Remission Undetermined 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 - 3 rd 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 or Subsequent Relapse - Sensitivity Unknown Post-Transplant Disease Status Hodgkin and Non-Hodgkin Lymphoma: CCR - Continued Complete Remission: patient transplanted in CR CR - Complete Remission: complete disappearance of all known disease for > 4 weeks CRU - Complete Remission Undetermined: CR, except with persistent scan abnormalities of unknown significance PR - Partial Remission: > 50% reductions in greatest diameter of all sites of known disease and no new sites NR / SD - No Response / Stable Disease: < 50% reduction in greatest diameter of all sites of known disease Rel / PD - Relapse / Progressive Disease: increase in size of known disease, or new sites of disease