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

January 2, 2024 updated by: Multiple Myeloma Research Foundation

A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to one year after baseline.
Survival rates
Time Frame: Five to eight years after baseline
Progression-free survival and overall survival
Five to eight years after baseline
Bone disease assessed radiographically
Time Frame: Baseline and during five to eight years of follow-up
Baseline and during five to eight years of follow-up
Health-related quality of life
Time Frame: Baseline and during five to eight years of follow-up
EORTC QLQ-C30 and QLQ-MY20
Baseline and during five to eight years of follow-up
Resource utilization
Time Frame: Baseline and during five to eight years of follow-up
Hospitalizations and ER visits
Baseline and during five to eight years of follow-up
Severe adverse events
Time Frame: Five to eight years
Severe/CTCAE grade 3-4 adverse events (checklist)
Five to eight years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Multiple Myeloma Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spectrum Health Hospitals
Translational Genomics Research Institute
Van Andel Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniel Auclair, Multiple Myeloma Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMRF-11-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Interim Analysis data will be released every 6 months

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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