Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Multiple Myeloma
Age (in years)
18+
Participants needed
1154
Est. Completion Date
Sep 30, 2023
Treatment type
Observational
Sponsor
Multiple Myeloma Research Foundation
ClinicalTrials.gov identifier
NCT01454297
Study number
MMRF-11-001
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