MMRF CoMMpass LONGITUDINAL STUDY MMRF-11-001 SM www.themmrf.org/CoMMpass CoMMpass Study Visit Reminders ■■ ECOG PS (q3mos) ■■ AE Assessment (all Grade 3 & 4 AEs must be entered into MedNet) ■■ QoL questionnaires (complete at baseline & annually) Assessment of Response to Treatment Assessment of treatment response must be evaluated using IMWG criteria & entered into MedNet every 3 months using the disease assessment labs collected as SOC. ■■ At a minimum, the labs should include the disease assessment lab used to confirm CoMMpass eligibility (SPEP, UPEP or SFLC) Assessment sCR CR Local Labs/Tests Required Central Labs Required ■■ FLC ratio and ■■ BMA ■■ BMA ■■ Peripheral Blood ■■ SPEP & serum immunofixation ■■ BMA ■■ UPEP & urine immunofixation ■■ Peripheral Blood ■■ Plasmacytoma evaluation (if present at baseline) ■■ BMA ■■ SFLC (if FLC disease only) PD ■■ SPEP and/or UPEP (if present at baseline ■■ SFLC (in SFLC disease only) ■■ BMA ■■ Peripheral Blood CoMMpass IMWG Criteria Response sCR IMWG Criteria CR as defined below plus: ■■ Normal FLC ratio and ■■ Absence of clonal cells in bone marrow by immunohistochemistry or 2- or 4- color flow cytometry CR ■■ Negative immunofixation of serum and urine and ■■ Disappearance of any soft tissue plasmacytomas and ■■ < 5% plasma cells in bone marrow ■■ In patients with only FLC disease, a normal FLC ratio of 0.26 – 1.65 is required VGPR ■■ Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ■■ ≥90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h ■■ In patients with only FLC disease, >90% decrease in the difference between involved and uninvolved FLC levels is required PR ■■ ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h ■■ If the serum and urine M-protein are not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria ■■ If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥30% ■■ In addition to the above criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required ■■ All response categories (CR, sCR, VGPR, and PD) require two consecutive assessments made at any time before the institution of any new therapy ■■ CR, sCR, VGPR, PR, and SD categories also require no known evidence of progressive or new bone lesions if radiographic studies were performed CoMMpass IMWG Criteria, Continued ■■ VGPR and CR categories require serum and urine studies regardless of whether disease at baseline was measurable on serum, urine, both or neither. Radiographic studies are not required to satisfy these response requirements. ■■ Bone marrow assessments need not be confirmed Stable Disease Progressive Disease ■■ Not meeting criteria for CR, VGPR, PR, or progressive disease Increase of ≥25% from lowest response value in any one of the following: ■■ Serum M-component (the absolute increase must be ≥0.5 g/dL) and/or ■■ Urine M-component (the absolute increase must be ≥200 mg/24 h) and/or ■■ Only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels (the absolute increase must be >10 mg/dL) ■■ Only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell percentage (the absolute % must be ≥10%) ■■ Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas ■■ Development of hypercalcemia (corrected serum calcium >11.5 mg/dL ) that can be attributed solely to the plasma cell proliferative disorder ■■ For progressive disease, serum M-component increases of ≥1 g/dL are sufficient to define response if starting M-component is ≥5 g/dL Bone marrow criteria for Progressive Disease are to be used only in patients without measurable disease by M protein and by FLC levels. A 25% increase refers to M protein, FLC, and bone marrow results and does not refer to bone lesions, soft tissue plasmacytomas or hypercalcemia. Note the lowest response value does not need to be a confirmed value. ECOG Performance Score Grade Description 0 ■■ Normal activity, fully active, able to carry on all pre-disease performance without restriction 1 ■■ Symptoms, but fully ambulatory, restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work) 2 ■■ Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 ■■ Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4 ■■ Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 ■■ Dead Abbreviations: ECOG = Eastern Cooperative Oncology Group ECOG Performance Status is required at each CoMMpass visit. Karnofsky’s / ECOG Conversion Table Status Karnofsky Grade ECOG Normal, no complaints 100 0 Fully active, able to carry on all pre-disease performance without restriction Able to carry on normal activities. Minor signs or symptoms of disease. 90 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Normal activity with effort 80 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Care for self. Unable to carry on normal activity or to do active work. 70 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Requires occasional assistance, but able to care for most of his needs 60 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Requires considerable assistance and frequent medical care 50 3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours Disabled. Requires special care and assistance. 40 3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours Severely disabled. Hospitalization indicated though death non-imminent. 30 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. Very sick. Hospitalization necessary. Active supportive treatment necessary. 20 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. Moribund 10 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. Dead 0 5 Dead
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