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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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