At a glance
ClinicalIndex Comparison Record- ✓Previously untreated multiple myeloma, Stage I, II, or III by International Staging System
- ✓Measurable M-protein: serum M-protein ≥1.0 g/dL OR urinary M-protein excretion ≥200 mg/24 hours
- ✓Age 18 years or older
- ✓Platelet count ≥80,000/mm³, ANC ≥1,000/mm³, Hemoglobin ≥9 g/dL (unless due to >50% marrow involvement)
- ✕Nonsecretory multiple myeloma
- ✕Planning to undergo autologous stem cell transplantation
- ✕Prior chemotherapy
- ✕Prior interferon or thalidomide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating dexamethasone, lenalidomide, and 1 other intervention for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 198 participants across 2 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.
Study Details
Timeline
Interventions
Given orally
Given orally
Given orally