Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM

Phase 2 Active not recruiting 198 enrolled Study Group of Medical Tumour Therapy (AGMT) Assign Data Management and Biostatistics GmbH · collab Medical University of Vienna · collab Sanofi · collab University of Navarra · collab WiSP GmbH · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. ln sum, a clear and clinically highly relevant benefit is expected with the isatuximab-based triple combination compared to the standard Rd doublet.

Timeline

Start: 2021-10-20
Primary completion: 2027-12
Completion: 2028-12

Publications

Background Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen WM, Kim K, Zamagni E, Rodriguez-Otero P, Renwick W, Rose C, Tempescul A, Boyle E, Manier S, Attal M, Moreau P, Macro M, Leleu X, Lorraine Chretien M, Ludwig H, Guo S, Sturniolo M, Tinel A, Silvia Monzini M, Costa B, Houck V, Hulin C, Yves Mary J. A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial. Leukemia. 2020 Jan;34(1):224-233. doi: 10.1038/s41375-019-0539-0. Epub 2019 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isatuximab	Monoclonal antibody	10 mg/kg	—
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Lenalidomide	Other / unclassified	5 mg	—
Background	Lenalidomide	Other / unclassified	10 mg	—

Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM

Summary

Timeline

Publications

Drugs

Indications