Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
CoMMpass
A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles
1 other identifier
observational
1,154
3 countries
73
Brief Summary
The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 7, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 3, 2024
January 1, 2024
12.4 years
October 7, 2011
January 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression.
Baseline to 8 years.
Secondary Outcomes (6)
Response rates
Up to one year after baseline.
Survival rates
Five to eight years after baseline
Bone disease assessed radiographically
Baseline and during five to eight years of follow-up
Health-related quality of life
Baseline and during five to eight years of follow-up
Resource utilization
Baseline and during five to eight years of follow-up
- +1 more secondary outcomes
Study Arms (1)
Newly diagnosed Multiple Myeloma
This is a prospective observational study in patients with symptomatic multiple myeloma who have not yet initiated therapy for their disease.
Eligibility Criteria
Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment
You may qualify if:
- Patient is at least 18 years old.
- Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
- Serum M protein ≥ 1g/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).
- The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
- No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
- Patient has read, understood and signed informed consent.
You may not qualify if:
- Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
- Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
- Patient is enrolled 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Multiple Myeloma Research Foundationlead
- Translational Genomics Research Institutecollaborator
- Corewell Health Westcollaborator
- Van Andel Research Institutecollaborator
Study Sites (73)
Mayo Clinic Campus in Scottsdale, AZ
Scottsdale, Arizona, 85259, United States
UC San Diego Moores Cancer Center
San Diego, California, 92093, United States
Sharp Health Care
San Diego, California, 92123, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Kaiser Permanente of Colorado
Denver, Colorado, 80205, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, 06907, United States
VA Medical Center, Washington DC,
Washington D.C., District of Columbia, 20422, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
University of Chicago
Chicago, Illinois, 60637, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Peninsula Regional Cancer Center
Salisbury, Maryland, 21801, United States
Holy Cross Hospital
Silver Spring, Maryland, 20902, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Mayo Clinic-Rochester
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Washington University
St Louis, Missouri, 63110, United States
Billings Clinic
Billings, Montana, 59101, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03784, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Broome Oncology
Johnson City, New York, 13790, United States
New York University Medical Center
New York, New York, 10016, United States
Mt Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, 10065, United States
St Francis Hospital
Roslyn, New York, 11576, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
Waverly Hematology Oncology
Cary, North Carolina, 27518, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
First Health Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
University of Texas Southwest Medical Center
Dallas, Texas, 75390, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
Central Texas VA Healthcare Center
Temple, Texas, 76504, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology- Waco
Waco, Texas, 76712, United States
Virginia Cancer Specialists PV
Fairfax, Virginia, 22013, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Tom Baker Cancer Centre, Alberta Health Services
Calgary, Alberta, T2N 2T9, Canada
Cross Cancer Institute, Alberta Health Services
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, H3A1A1, Canada
Hospital Clinica Universitari Lozano Blesa
Zaragoza, Aragon, 50012, Spain
Hospital Univ Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Son Llàtze
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital University de Salamanca
Salamanca, Castille and León, 37007, Spain
H. U. Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital Quirón de Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
University Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitari de Canarias
Santa Cruz de Tenerife, Santa Cruz, 38320, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Santa Creu I Sant Pau
Barcelona, 08026, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Puerta de Hierro
Madrid, 28222, Spain
Related Publications (4)
Auclair D, Mansfield C, Fiala MA, Chari A, Cole CE, Kaufman JL, Orloff GJ, Siegel DS, Zonder JA, Mange B, Yesil J, Dalal M, Mikhael JR. Preferences and Priorities for Relapsed Multiple Myeloma Treatments Among Patients and Caregivers in the United States. Patient Prefer Adherence. 2022 Mar 1;16:573-585. doi: 10.2147/PPA.S345906. eCollection 2022.
PMID: 35256844DERIVEDBarwick BG, Gupta VA, Matulis SM, Patton JC, Powell DR, Gu Y, Jaye DL, Conneely KN, Lin YC, Hofmeister CC, Nooka AK, Keats JJ, Lonial S, Vertino PM, Boise LH. Chromatin Accessibility Identifies Regulatory Elements Predictive of Gene Expression and Disease Outcome in Multiple Myeloma. Clin Cancer Res. 2021 Jun 1;27(11):3178-3189. doi: 10.1158/1078-0432.CCR-20-2931. Epub 2021 Mar 17.
PMID: 33731366DERIVEDFoltz SM, Gao Q, Yoon CJ, Sun H, Yao L, Li Y, Jayasinghe RG, Cao S, King J, Kohnen DR, Fiala MA, Ding L, Vij R. Evolution and structure of clinically relevant gene fusions in multiple myeloma. Nat Commun. 2020 May 29;11(1):2666. doi: 10.1038/s41467-020-16434-y.
PMID: 32471990DERIVEDMiller A, Asmann Y, Cattaneo L, Braggio E, Keats J, Auclair D, Lonial S; MMRF CoMMpass Network; Russell SJ, Stewart AK. High somatic mutation and neoantigen burden are correlated with decreased progression-free survival in multiple myeloma. Blood Cancer J. 2017 Sep 22;7(9):e612. doi: 10.1038/bcj.2017.94.
PMID: 28937974DERIVED
Related Links
Biospecimen
Bone marrow, Peripheral Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Auclair
Multiple Myeloma Research Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2011
First Posted
October 19, 2011
Study Start
July 1, 2011
Primary Completion
November 30, 2023
Study Completion
December 31, 2023
Last Updated
January 3, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
Interim Analysis data will be released every 6 months