- Active, not recruiting
NCT04270409: Phase 3 - Isatuximab in Combination With Lenalidomide and Dex High-risk SMM (ITHACA)
Updated: Feb 21
(ITHACA)
High-risk Smoldering Multiple Myeloma
NCT04270409
NCT04270409: Phase 3 - Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma (ITHACA)
Sponsor: Sanofi
Primary Objectives:
Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in participants with high-risk SMM
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT04270409
Official Title: A Phase 3 Randomized, Open Label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma
First Posted: February 17, 2020
Click here to see details on ClinicalTrials.gov
Drug: Isatuximab SAR650984
Drug: Lenalidomide
Drug: Dexamethasone
Isatuximab in Combination with Lenalidomide and Dexamethasone in Patients with High-Risk Smoldering Multiple Myeloma: Updated Safety Run-in Results from the Randomized Phase 3 Ithaca Study
653.MYELOMA AND PLASMA CELL DYSCRASIAS: PROSPECTIVE THERAPEUTIC TRIALS| NOVEMBER 15, 2022
Locations
United States, Colorado
United States, Florida
United States, Massachusetts
United States, North Carolina
United States, Tennessee
United States, Texas
Canada, Alberta
Canada, New Brunswick
Canada, Quebec
Brazil
Europe
United Kingdom
France
Germany
Italy
Spain
Czechia
Denmark
Greece
Hungary
Ireland
Lithuania
Norway
Poland
Sweden
Asia
China
Japan
Israel
Korea, Republic of
Turkey
Australia, New South Wales
Australia, Victoria
Australia, Western Australia
New Zealand