Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
- Conditions
- Multiple Myeloma
- Registration Number
- NCT01454297
- Lead Sponsor
- Multiple Myeloma Research Foundation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1154
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. 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
Name Time Method Resource utilization Baseline and during five to eight years of follow-up Hospitalizations and ER visits
Response rates Up to one year after baseline. IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response.
Survival rates Five to eight years after baseline Progression-free survival and overall survival
Bone disease assessed radiographically Baseline and during five to eight years of follow-up Health-related quality of life Baseline and during five to eight years of follow-up EORTC QLQ-C30 and QLQ-MY20
Severe adverse events Five to eight years Severe/CTCAE grade 3-4 adverse events (checklist)
Trial Locations
- Locations (73)
Mayo Clinic Campus in Scottsdale, AZ
🇺🇸Scottsdale, Arizona, United States
UC San Diego Moores Cancer Center
🇺🇸San Diego, California, United States
Sharp Health Care
🇺🇸San Diego, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Kaiser Permanente of Colorado
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Carl and Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
VA Medical Center, Washington DC,
🇺🇸Washington, District of Columbia, United States
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