Status:
COMPLETED
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
Lead Sponsor:
Multiple Myeloma Research Foundation
Collaborating Sponsors:
Translational Genomics Research Institute
Corewell Health West
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
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 personal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
1154 Patients enrolled
Trial Details
Trial ID
NCT01454297
Start Date
July 1 2011
End Date
December 31 2023
Last Update
January 3 2024
Active Locations (73)
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1
Mayo Clinic Campus in Scottsdale, AZ
Scottsdale, Arizona, United States, 85259
2
UC San Diego Moores Cancer Center
San Diego, California, United States, 92093
3
Sharp Health Care
San Diego, California, United States, 92123
4
VA San Diego Healthcare System
San Diego, California, United States, 92161