• Recruiting

NCT04270409: Phase 3 - Isatuximab in Combination With Lenalidomide and Dex High-risk SMM (ITHACA)

Updated: May 23

(ITHACA)

High-risk Smoldering Multiple Myeloma

NCT04270409

ITHACA Isatuximab

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

 

Dexamethasone : National Cancer Institute

Isatuximab : National Cancer Institute

Dexamethasone : National Cancer Institute

 

Drug: Isatuximab SAR650984

Drug: Lenalidomide

Drug: Dexamethasone

 

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




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