Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
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 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|
- Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. [ Time Frame: Baseline to 5years. ] [ Designated as safety issue: No ]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.
- Response rates [ Time Frame: Up to one year after baseline. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Progression-free survival and overall survival
- Bone disease assessed radiographically [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]EORTC QLQ-C30 and QLQ-MY20
- Resource utilization [ Time Frame: Baseline and during five to eight years of follow-up ] [ Designated as safety issue: No ]Hospitalizations and ER visits
- Severe adverse events [ Time Frame: Five to eight years ] [ Designated as safety issue: Yes ]Severe/CTCAE grade 3-4 adverse events (checklist)
Biospecimen Retention: Samples With DNA
Bone marrow, Peripheral Blood
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2019 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454297
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|Study Director:||Daniel Auclair||Multiple Myeloma Research Foundation|