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The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
A Prospective, Longitudinal,
Observational Study in Newly
Diagnosed Multiple Myeloma Patients
to Assess the Relationship Between
Patient Outcomes, Treatment
Regimens, and Molecular Profiles
The Multiple Myeloma Research Foundation
CoMMpass Study
Sagar Lonial, MD
Co-Principal Investigator
Emory University
Atlanta, Georgia
Introduction
• Purpose
– To identify the molecular profiles and clinical
characteristics that define subsets of myeloma
patients at initial diagnosis and at relapse of disease
• Primary outcome
– Response rate (as defined by International Myeloma
Working Group criteria), progression-free survival,
overall survival, health-related quality of life, and
biologic profiling and genomic marker studies on
bone marrow tumor cells and peripheral blood at
baseline pre-treatment, at first subsequent
relapse/progression, and at suspected complete
response
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Longitudinal Study Designed to Identify Patient
Segments Based on Molecular Profiling
CoMMpass Trial
Target enrollment:
>1,000 newly diagnosed patients
Clinical data and
tissue profiling
Core molecular tests:
Duration:
• Flow cytometry
~13 years (3-year enrollment
• RNA sequencing expression analysis
+ 5-year full F/U and 5=year
• Whole-exome DNA sequencing
survival F/U)
• Whole-genome chromosome analysis
• Cytospin slides for FISH
Target 50 centers
PCC Partners
Onyx, Millennium, BMS, JNJ
CoMMpass, Relating Clinical Outcomes in MM to Personal Assessment of Genetic Profile
Inclusion Criteria
• Male/female ≥18 years of age
• Symptomatic multiple myeloma with measurable
disease that includes at least one of the following:
– Serum M protein ≥1 g/dL
– Urine M protein ≥200 mg/24 hrs
– Involved free light chain level ≥10 mg/dL and an abnormal
serum free light chain ratio (<0.26 or >1.65)
• Candidate for systemic therapy that includes an
immunomodulator drug (IMiD) and/or proteasome
inhibitor as part of the initial regimen
• No more than 30 days from baseline bone marrow
evaluation to initiation of therapy
• Be able to read, understand, and sign the Informed
Consent document
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Exclusion Criteria
• Currently receiving systemic therapy for multiple
– Please note that a single dose of bisphosphonates and up
to 100 mg total dose of dexamethasone or equivalent
corticosteroids are permitted prior to study registration.
• Prior (within the last 5 years) malignancy
– Exceptions include basal or squamous cell carcinoma or in
situ cancer of the cervix
• Enrollment in a blinded clinical trial for the first-line
treatment of multiple myeloma
– Patients may be enrolled in subsequent clinical trials as
long as continued access to data and tissue, as per this
protocol, is not prohibited
Trial Schema
Active multiple myeloma, newly diagnosed, untreated
(n=1,000)
Clinical
end points: Baseline
Treatment 1 Response
Relapse/progression
Treatment 2 CR/Relapse/PD
First-line therapy:
≥Second-line
IMiD, proteasome
therapy: (single
inhibitor, GC (single
or comb.)
or comb.)
Clinical study
Biospecimen
colletion:
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
Biospecimen Workflow
Isolation of tumor
Speciment collection
cells: CD138+ MM
and processing
(<24 h)
purification
Whole-genome
Isolation of control
cells: CD3+ T cells
Whole-exome
Bone marrow aspirate
Circulating tumor
+ peripheral blood
Specimen QC:
Cytomorphology
flow cytometry,
PI, DNA ploidy
Immunophenotyping
%PC, %CD138…et al
BioRepository:
(MM panel)
CD138+/CD138-/PBL CD3+
DNA/RNA/protein/plasma
%PC, %CD138…et al
cell cryopreservation
CoMMpass Genomics
Bringing state-of-the-art next-generation sequencing to
MM patients at both community and academic centers
Patients can
Community
Academic
MMRF CoMMpass
obtain w/o
academic &
physician
availability
availability
community centers
Exome normal tissue
sequencing
MM tumor purification and
MM tumor exome
sequencing
MM tumor RNA sequencing
MM tumor flow cytometry
• yes, paid by patient
* Insurance reimbursement is evolving
▲ may be paid as part of research program
+/- ordered by a limited number of centers
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
CoMMpass Data
We will be performing interim
analyses of the data every 6 months.
Contact Information
• For more information on becoming a site, or
if you would like to refer a patient to the
MMRF CoMMpass Study, please contact
Beverly Harrison at [email protected]
or call 203.652.0213
Relating Clinical Outcomes in Multiple Myeloma to
Personal Assessment of Genetic Profile (CoMMpass)
NCT01454297
This material serves as an educational resource only.
The Multiple Myeloma Research Foundation CoMMpass Study
Sagar Lonial, MD
If you want to learn more, you are
invited to attend a CME-certified
regional lecture series
A Personalized Approach to Multiple
Myeloma Treatment
Call toll-free: (888) 576-6968
to participate in a city near you:
Chicago, Illinois
Atlanta, Georgia
New York, New York
This material serves as an educational resource only.

Source: http://www.oncology.tv/portals/0/linkedFiles/MMRF_Community_Case_Discussion.pdf