- Active, not recruiting
NCT03412565: Phase 2 - Subcutaneous Daratumumab in Combination With Standard MM Regimens - PLEIADES
Updated: May 24, 2022
PLEIADES study
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimen
MMY2040 (PLEIADES) Study
NDMM : Newly diagnosed Multiple Myeloma
RRMM : Relapsed & Refractory Multiple Myeloma
PLEIADES is a multicentre, open-label, Phase II study to investigate the safety and efficacy of DARA SC with standard-of-care regimens, including VRd (D-VRd) in patients with NDMM who are eligible for autologous stem cell transplant (ASCT), VMP (D-VMP) in ASCT-ineligible patients with NDMM and Rd (D-Rd) in patients with RRMM who received ≥1 prior line of therapy
Experimental: Daratumumab(D) + Bortezomib + Lenalidomide + Dexamethasone (D-VRd)
Experimental: Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP)
Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
Sponsor
Janssen Research & Development, LLC
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT03412565
Official Title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
First Posted : January 26, 2018
Click here for details on ClinicalTrials.gov
Drug: Daratumumab
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Carfilzomib
Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study
Br J Haematol; 2021 March
1380 Subcutaneous Daratumumab (DARA SC) Plus Standard-of-Care (SoC) Regimens in Multiple Myeloma (MM) across Lines of Therapy in the Phase 2 Pleiades Study: Initial Results of the Dara SC Plus Carfilzomib/Dexamethasone (D-Kd) Cohort, and Updated Results for the Dara SC Plus Bortezomib/Melphalan/Prednisone (D-VMP) and Dara SC Plus Lenalidomide/Dexamethasone (D-Rd) Cohorts
62nd ASH Annual Meeting
Saturday, December 5, 2020
- Multiple locations
- Florida: Mayo Clinic Jacksonville Florida
- New York: NYU Langone Medical Center New York
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- North Carolina: Wake Forest Baptist Health Winston-Salem
Locations
United States, Connecticut
United States, Florida
United States, Idaho
United States, Michigan
United States, Montana
United States, Nebraska
United States, New Mexico
United States, New York
United States, North Carolina
United States, South Carolina
United States, South Dakota
United States, Utah
United States, Virginia
Brazil
Europe
United Kingdom
France
Germany
Spain
Czechia
Asia
Israel
Japan
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