At a glance
ClinicalIndex Comparison Record- ✓Documented multiple myeloma meeting CRAB criteria or ≥10% plasma cells with measurable disease
- ✓Newly diagnosed, not eligible for high-dose chemotherapy: age ≥65 or <65 with significant comorbidities
- ✓ECOG performance status 0, 1, or 2
- ✕Primary amyloidosis, MGUS, or smoldering multiple myeloma
- ✕Waldenström's disease or IgM M protein without clonal plasma cell infiltration
- ✕Prior malignancy within 5 years (except skin cancer or cervical carcinoma in situ)
- ✕Prior systemic therapy or stem cell transplant for multiple myeloma (except emergency short-course corticosteroids)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
In Brief
A Phase 3 clinical trial evaluating Daratumumab IV, Lenalidomide, and 2 other interventions for Multiple Myeloma. Completed, enrolled 737 participants across 206 sites in 13 countries.
Detailed Summary
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Study Details
Timeline
Interventions
Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.
Dexamethasone 40 mg orally or intravenously once in a week.
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.