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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

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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

Groups and Cohorts

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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.

Outcome Measures

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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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 73 Study Locations

Sponsors and Collaborators

Multiple Myeloma Research Foundation

Translational Genomics Research Institute

Spectrum Health Hospitals

Van Andel Research Institute

Investigators

Study Director:	Daniel Auclair	Multiple Myeloma Research Foundation

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The Multiple Myeloma Research Foundation 

Responsible Party:	Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier:	NCT01454297 History of Changes
Other Study ID Numbers:	MMRF-11-001
First Posted:	October 19, 2011
Last Update Posted:	September 27, 2016
Last Verified:	August 2016
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:

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