Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
This study is ongoing, but not recruiting participants.
Sponsor:
Multiple Myeloma Research Foundation
ClinicalTrials.gov Identifier:
NCT01454297
First Posted: October 19, 2011
Last Update Posted: September 27, 2016
Collaborators:
Translational Genomics Research Institute
Spectrum Health Hospitals
Van Andel Research Institute
Information provided by (Responsible Party):
Multiple Myeloma Research Foundation
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Purpose
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 |
|---|
| Multiple Myeloma |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by Multiple Myeloma Research Foundation:
Primary Outcome Measures:
- 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:
- 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)
Biospecimen Retention: Samples With DNA
Bone marrow, Peripheral Blood
| Enrollment: | 1154 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2023 |
| Estimated Primary Completion Date: | September 2023 (Final data collection date for primary outcome measure) |
| 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.
|
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.
Eligibility
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.
| 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
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
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
Additional Information:
| Responsible Party: | Multiple Myeloma Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01454297 History of Changes |
| Other Study ID Numbers: |
MMRF-11-001 |
| First Submitted: | October 7, 2011 |
| 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 |