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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

Tracking Information
First Submitted Date October 7, 2011
First Posted Date October 19, 2011
Last Update Posted Date August 16, 2018
Study Start Date July 2011
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2016)
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.
Original Primary Outcome Measures
 (submitted: October 14, 2011)
Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 5years. ]
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.
Change History Complete list of historical versions of study NCT01454297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 14, 2011)
  • 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.
  • Survival rates [ Time Frame: Five to eight years after baseline ]
    Progression-free survival and overall survival
  • Bone disease assessed radiographically [ Time Frame: 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
  • Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ]
    Hospitalizations and ER visits
  • Severe adverse events [ Time Frame: Five to eight years ]
    Severe/CTCAE grade 3-4 adverse events (checklist)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
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
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bone marrow, Peripheral Blood
Sampling Method Non-Probability Sample
Study Population Newly diagnosed, symptomatic, multiple myeloma, candidates for systemic treatment
Condition Multiple Myeloma
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Miller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 25, 2016)
1154
Original Estimated Enrollment
 (submitted: October 14, 2011)
1000
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States,   Canada,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01454297
Other Study ID Numbers MMRF-11-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Interim Analysis data will be released every 6 months
Responsible Party Multiple Myeloma Research Foundation
Study Sponsor Multiple Myeloma Research Foundation
Collaborators
  • Translational Genomics Research Institute
  • Spectrum Health Hospitals
  • Van Andel Research Institute
Investigators
Study Director: Daniel Auclair Multiple Myeloma Research Foundation
PRS Account Multiple Myeloma Research Foundation
Verification Date August 2018