Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2029-11-01

Summary

Background of the study: The combination of daratumumab with VRd is anticipated to further improve response rates in patients and may lead to improved long-term outcomes in newly diagnosed patients with multiple myeloma. Given this potential, and based upon the initial safety and efficacy observed in the ongoing Phase 2 Study MMY2004, as well as continued positive results with daratumumab in various disease settings and combination regimens, this Phase 3 study is designed to demonstrate improved outcomes for patients treated with daratumumab+VRd. The Phase 3 study will utilize the subcutaneous (SC) formulation of daratumumab instead of the IV formulation utilized in the Phase 2 study, which may limit additional toxicity to patients treated with the quadruplet regimen.

• Phase: Phase 3

Details

• Lead Sponsor: European Myeloma Network
• Collaborator: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate; Lenalidomide; Thalidomide