NCT04653246

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Jacob Laubach, MD · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Myeloma
• Newly Diagnosed Multiple Myeloma (NDMM)
• Autologous Stem Cell Transplant

Interventions

Type	Name	Description
DRUG	Isatuximab	Via IV at predetermined dosage and predetermined days during each cycle
DRUG	Lenalidomide	Oral, predetermined dosage and predetermined days during each cycle
DRUG	Bortezomib Injection	SQ Oral, predetermined dosage and predetermined days during each cycle
DRUG	Dexamethasone	IV or Oral predetermined dosage and predetermined days during each cycle

Timeline

• Start date: 2021-07-13
• Primary completion: 2025-12-15
• Completion: 2029-01-13
• First posted: 2020-12-04
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study