Lenalidomide and dexamethasone, with or without daratumumab
Treatments studied
Part of Blood & lymphatic, Cancer, Immune system & allergy clinical trials.
This phase 3 trial studies whether lenalidomide plus dexamethasone can prevent or delay progression of “high-risk smoldering” multiple myeloma, and whether adding daratumumab improves outcomes. It’s meant for people who are not yet showing symptoms, but whose lab and scan results suggest higher risk.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You were diagnosed with high-risk smoldering multiple myeloma in the last 12 months and are currently without myeloma symptoms.
- You must meet “high-risk” criteria (at least 2 factors such as abnormal blood light-chain ratio, higher M-protein level, specific chromosome changes, or higher plasma cells on biopsy).
- Recent tests are required: bone marrow test (10–59% clonal plasma cells within 42 days), and blood/urine protein tests and blood free light chains within set time windows.
- You must not have bone damage (no lytic lesions), no plasmacytoma, and no unexplained high calcium level.
- Your blood counts and organ function need to be high enough (for example hemoglobin, platelets, neutrophils, kidney function, and liver tests).
- You must not have prior myeloma treatment; you also must be able to safely take blood-thinner/DVT prevention if needed, and you must avoid pregnancy while on treatment.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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