- Active, not recruiting
NCT03710603: Phase 3 - Daratumumab, VELCADE, Len, Dex VS VELCADE, Len, Dex in NDMM (Perseus) EMN17
Updated: Feb 4
Perseus Study
NDMM
Newly Diagnosed Multiple Myeloma
EMN 17
Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma (Perseus)
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.
Sponsor
Collaborator
ClinicalTrials.gov Identifier: NCT03710603
Official Title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy
First Posted: October 18, 2018
Click here for details on ClinicalTrials.gov
EudraCT number, 2018-002992-16
Drug: Daratumumab
Drug: velcade
Drug: Lenalidomide
Drug: dexamethasone
Locations
Australia
Europe
France
Italy
Netherlands
Spain
Belgium
Czechia
Denmark
Greece
Norway
Poland
Switzerland
Turkey
CONCLUSIONS: The addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy conferred a significant benefit with respect to progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma.
Program: General Sessions
Session: Late-Breaking Abstracts Session
Hematology Disease Topics & Pathways:
Research, Biological therapies, Clinical Research, Combination therapy, Diseases, Therapies, Lymphoid Malignancies, Study Population, Human - Tuesday, December 12, 2023, 9:00 AM-10:30 AM
Conclusions: DARA SC combined with VRd in transplant-eligible pts with NDMM significantly improved PFS and increased depth of response (≥CR and MRD negativity), with consistent PFS benefit across clinically relevant subgroups. The safety profile was consistent with the known safety profiles for DARA SC and VRd. These data, together with results from the phase 2 GRIFFIN study, demonstrate the consistent and clinically meaningful benefit of quadruplet DARA plus VRd followed by D-R maintenance versus triplet VRd followed by R maintenance and support the combination of DARA plus VRd followed by D-R maintenance as a new standard of care for transplant-eligible NDMM.
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