NCT03993912: Phase 3 - Lenalidomide & SC Daratumumab vs Lenalidomide and Dex in NDMM - (IFM2017_03)
Updated: Feb 10
IFM2017_03
NCT03993912: Phase 3 - Lenalidomide and SC Daratumumab vs Lenalidomide and Dexamethasone in NDMM(IFM2017_03)
This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT
Sponsor
University Hospital, Lille
IFM
French Study
ClinicalTrials.gov Identifier: NCT03993912
Official Title: A Phase III Study Comparing Lenalidomide and Subcutaneous Daratumumab (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
First Posted : June 21, 2019
Click here to see details on ClinicalTrials.gov
Drug: Daratumumab SC in combination with Lenalidomide
Drug: Lenalidomide PO (25mg)
Drug: Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
Location
Europe
France