Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Identifier: NCT01454297
Recruitment Status : Active, not recruiting
First Posted : October 19, 2011
Last Update Posted : August 16, 2018
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.

Layout table for study information
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

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.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01454297

Show Show 73 study locations
Sponsors and Collaborators
Multiple Myeloma Research Foundation
Translational Genomics Research Institute
Spectrum Health Hospitals
Van Andel Research Institute
Layout table for investigator information
Study Director: Daniel Auclair Multiple Myeloma Research Foundation
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Multiple Myeloma Research Foundation 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:
Multiple Myeloma
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases