Spots Global Cancer Trial Database for Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

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Trial Identification

Brief Title: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

Official Title: Phase 2, Multi-Center, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Study ID: NCT04653246

Conditions

Multiple Myeloma

Newly Diagnosed Multiple Myeloma (NDMM)

Autologous Stem Cell Transplant

Interventions

Study Description

Brief Summary: This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.

Detailed Description: This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem cell transplant (ASCT). In this research study, investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide, bortezomib, and dexamethsone. * This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide, bortezomib, and dexamethasone. * This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasn't been approved.