Collaboration to collect Autologous transplant outcomes in Lymphoma and Myeloma (CALM) Additional Questionnaire (MED C) INCLUSION CRITERIA CALM STUDY

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Elvin Norris
8 years ago
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1 Additional Questionnaire (MED C) CALM study Inclusion period: 01/01/2008 to 31/12/2011 PATIENT REGISTRATION FORM Disease Diagnosis Lymphoma S Non Hodgkin Lymphoma (NHL) Mature B-cell neoplasm Follicular lymphoma Grade I II III DISHGRD INCLUSION CRITERIA CALM STUDY Not evaluated Unknown Mantle cell lymphoma Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALTlymphoma) Diffuse large B-cell lymphoma Intravascular Mediastinal Primary effussion Burkitt lymphoma High grade B-cell lymphoma, Burkitt-like (provisional entity) Lymphoplasmacytic lymphoma Waldenstrom macroglobulinaemia Splenic marginal zone lymphoma Mature T-cell and NK-cell neoplasms Angioimmunoblastic T-cell lymphoma (AILD) Peripheral T-cell lymphoma, all types Anaplastic large cell, T/null cell, primary cutaneous Anaplastic large cell, T/null cell, primary systemic Extranodal NK/T cell lymphoma, nasal type Enteropathy type T-cell lymphoma Hepatosplenic gamma-delta T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Adult T-cell lymphoma/leukaemia (HTLV1+) Aggressive NK-cell leukaemia Large T-cell granular lymphocytic lymphoma Mycosis fungoides Sezary Syndrome Nodal marginal zone B-cell lymphoma Other T/NK-cell, specify Primary CNS lymphoma Other B-cell, specify Transformed from another disease or another type of lymphoma No VSECORIG Yes Unknown Hodgkin Lymphoma Nodular lymphocyte predominant Lymphocyte rich Nodular sclerosis Mixed cellularity Lymphoma depleted Other, specify Other Lymphoma, specify VDIAGTX 1

(MALTlymphoma) Diffuse large B-cell lymphoma Intravascular Mediastinal Primary effussion Burkitt lymphoma High grade B-cell lymphoma, Burkitt-like (provisional entity) Lymphoplasmacytic lymphoma

2 Disease Diagnosis MM Classification IG CHAIN TYPE LIGHT CHAIN TYPE SALMON & DURIE STAGE AT DIAGNOSIS Multiple myeloma IgG VPLCEDS1 Kappa VPLCEDS4 (Multiple Myeloma only) Multiple myeloma IgA VPLCEDS2 Lambda l and A Multiple myeloma IgD li B Multiple myeloma IgE III VSTGDST VSALMDUR Multiple myeloma IgM (not Waldenstrom) Multiple myeloma-light chain only VPLCEDS3 Multiple myeloma-non-secretory Patient is 18 years at day of first transplant yes no Patient received auto PBSC transplant using cells with yes no one of the following mobilisation regimens (please mark the one applicable): G-CSF alone G-CSF + chemotherapy Plerixafor + G-CSF Plerixafor + G-CSF + chemotherapy Patient diagnosed with MM or Lymphoma and all criteria above ticked? NO First transplant between 01/01/2008 and 31/12/2011? Was Plerixafor used in the mobilisation treatment? (non label indication*) Eligible for the CALM study (see label indication*). Please complete questions next page + MED B + Autograft form for MM or Lymphoma Eligible for Plerixafor Offlabel Transplant Use study. Please complete Off-label MED C form. *Label indication: Plerixafor is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly 2

Patient is 18 years at day of first transplant yes no Patient received auto PBSC transplant using cells with yes no one of the following mobilisation regimens (please mark the one applicable): G-CSF

3 TEAM CIC l l l l l l Hospital name Contact person: Date of this report.../.../...dat1stre PATIENT Unique Identification Code (UIC) (to be entered only if patient previouslyreported) Hospital Unique Patient Number ME Date of birth.../.../... Date of HSCT :.../.../...DAT1STRE ADDITIONAL QUESTIONS Patient is a proven poor mobiliser: If yes In a previous mobilisation attempt, patient has failed to mobilise sufficient CD34+ cells in the peripheral blood to proceed to apheresis Please record the CD34+ cell count used in this decision: CD34+ cells/ul In a previous mobilisation attempt, patient failed to collect sufficient cells to be able to proceed to transplantation In the current mobilisation attempt, peripheral blood CD34+ cell levels have failed to rise sufficiently at the predicted time for peak mobilization Please record the CD34+ cell count used in this decision: CD34+ cells/ul 3

ADDITIONAL QUESTIONS Patient is a proven poor mobiliser: If yes In a previous mobilisation attempt, patient has failed to mobilise sufficient CD34+ cells in the peripheral blood to proceed to

4 Patient is a predicted poor mobiliser If yes (please check all that apply) Reasons Prior irradiation to marrow-bearing areas High exposure to marrow-damaging chemotherapy (e.g., drug type, number of cycles, and/or number of regimens) Other,.. If available, please record the pre-apheresis peripheral blood CD34+ level: cells/ ul Patient is NOT a poor mobiliser: N.B. In case plerixafor is used, please use the off-label study form! (the use of plerixafor in patients who are NOT poor mobilisers is considered off label use). PBSC mobilisation course Bone marrow involvement at start of mobilisation regimen Blood volume processed 4

. If available, please record the pre-apheresis peripheral blood CD34+ level: cells/ ul Patient is NOT a poor mobiliser: N.B.

5 ONLY IF FIRST AUTOLOGOUS TRANSPLANT WAS FOR LYMPHOMA AT DIAGNOSIS: Hb (g/dl) ,... Not evaluated Unknown STATUS OF DISEASE AT COLLECTION IMMEDIATELY PRIOR TO MOBILISING CHEMOTHERAPY AND/OR GROWTH FACTOR IF USED VDISEST If patient has ever achieved Complete remission VDISESTA Complete remission (CR) NUMBER OF THIS REMISSION Unconfirmed 1 st VNUMSTM Confirmed: By CT scan VCRCONFI 2 nd By PET 3 rd or higher Relapse NUMBER OF THIS RELAPSE VNUMSTM TYPE OF RELAPSE VSENSIT 1 st Untreated (untested) 2 nd Sensitive (responding) 3 rd or higher Resistant If patient has never achieved a Complete remission Stable disease Primary refractory disease Very good 1 st PR (> 90 %) PR NUMBER OF THIS PR VNUMSTM 1 st 2 nd 3 rd or higher Progression VDISESTA 2 nd HSCT?, date.../.../... Plerixafor used for mobilisation at 2 nd HSCT Did relapse occur after 2 nd HSCT?, date.../.../... 5

$Untreated (untested) 2 nd Sensitive (responding) 3 rd or higher Resistant If patient has never achieved a Complete remission Stable disease Primary refractory disease Very good 1 st PR (> 90 %) PR$

Non-Hodgkin s Lymphoma

Non-Hodgkin s Lymphoma Luis Fayad, MD Assistant Professor Clinical Medical Director Lymphoma/Myeloma Department Non-Hodgkin s Lymphoma Non-Hodgkin s lymphomas (NHL) are a heterogeneous group of malignant