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Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01454297
Recruitment Status : Active, not recruiting
First Posted : October 19, 2011
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
Translational Genomics Research Institute
Spectrum Health Hospitals
Van Andel Research Institute
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation

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.

Condition or disease
Multiple Myeloma

Detailed Description:
Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

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Study Type : Observational
Actual Enrollment : 1154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles
Study Start Date : July 2011
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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.



Primary Outcome Measures :
  1. Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 8 years. ]
    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.


Secondary Outcome Measures :
  1. Response rates [ Time Frame: Up to one year after baseline. ]
    IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.

  2. Survival rates [ Time Frame: Five to eight years after baseline ]
    Progression-free survival and overall survival

  3. Bone disease assessed radiographically [ Time Frame: Baseline and during five to eight years of follow-up ]
  4. Health-related quality of life [ Time Frame: Baseline and during five to eight years of follow-up ]
    EORTC QLQ-C30 and QLQ-MY20

  5. Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ]
    Hospitalizations and ER visits

  6. Severe adverse events [ Time Frame: Five to eight years ]
    Severe/CTCAE grade 3-4 adverse events (checklist)


Biospecimen Retention:   Samples With DNA
Bone marrow, Peripheral Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454297


Locations
Hide Hide 73 study locations
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United States, Arizona
Mayo Clinic Campus in Scottsdale, AZ
Scottsdale, Arizona, United States, 85259
United States, California
UC San Diego Moores Cancer Center
San Diego, California, United States, 92093
Sharp Health Care
San Diego, California, United States, 92123
VA San Diego Healthcare System
San Diego, California, United States, 92161
San Francisco VA Medical Center
San Francisco, California, United States, 94121
UCSF Medical Center
San Francisco, California, United States, 94143
United States, Colorado
Kaiser Permanente of Colorado
Denver, Colorado, United States, 80205
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Connecticut
Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, United States, 06907
United States, District of Columbia
VA Medical Center, Washington DC,
Washington, District of Columbia, United States, 20422
United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34471
United States, Georgia
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Maryland
Peninsula Regional Cancer Center
Salisbury, Maryland, United States, 21801
Holy Cross Hospital
Silver Spring, Maryland, United States, 20902
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Washington University
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03784
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Broome Oncology
Johnson City, New York, United States, 13790
New York University Medical Center
New York, New York, United States, 10016
Mt Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, United States, 10065
St Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Waverly Hematology Oncology
Cary, North Carolina, United States, 27518
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Hospital
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27834
First Health Outpatient Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
University of Texas Southwest Medical Center
Dallas, Texas, United States, 75390
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Central Texas VA Healthcare Center
Temple, Texas, United States, 76504
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Texas Oncology- Waco
Waco, Texas, United States, 76712
United States, Virginia
Virginia Cancer Specialists PV
Fairfax, Virginia, United States, 22013
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99202
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Tom Baker Cancer Centre, Alberta Health Services
Calgary, Alberta, Canada, T2N 2T9
Cross Cancer Institute, Alberta Health Services
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1
Spain
Hospital Clinica Universitari Lozano Blesa
Zaragoza, Aragón, Spain, 50012
Hospital University de Salamanca
Salamanca, Castilla-León, Spain, 37007
H. U. Germans Trias i Pujol
Badalona, Cataluña, Spain, 08916
Hospital Univ Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07120
Hospital Son Llàtze
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Quirón de Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
University Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain, 28702
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitari de Canarias
Tenerife, Santa Cruz, Spain, 38320
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu I Sant Pau
Barcelona, Spain, 08026
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Puerta de Hierro
Madrid, Spain, 28222
Sponsors and Collaborators
Multiple Myeloma Research Foundation
Translational Genomics Research Institute
Spectrum Health Hospitals
Van Andel Research Institute
Investigators
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Study Director: Daniel Auclair Multiple Myeloma Research Foundation

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier: NCT01454297    
Other Study ID Numbers: MMRF-11-001
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Interim Analysis data will be released every 6 months
Keywords provided by Multiple Myeloma Research Foundation:
Myeloma
Multiple Myeloma
Observational
Longitudinal
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases