NCT05776979

Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

To learn if isatuximab can help to control highrisk MM when given in combination with lenalidomide after an autologous stem cell transplantation (ASCT).

Detailed description

Objectives: Primary Objectives 1\. Compare progression-free survival at 3 years with historical control rate of 50%. Primary endpoint 1\. Progression-free survival at 3 years, measured from the date of transplant to the date of progression or death. Secondary objectives: 1. Assess minimal residual disease (MRD) rate at 12 months after starting Isatuximab maintenance therapy 2. Assess overall best response rate (defined as the occurrence of VGPR or better and CR/sCR) before the 4th Isatuximab cycle, and at 12, 24, and 36 months after starting maintenance therapy 3. Assess MRD rate before 4th Isatuximab cycle and at 24 months after starting maintenance therapy 4. Assess duration of response (DOR) 5. Assess overall survival (OS) 6. Assess safety

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	Given by vein over about 75 minutes
DRUG	lenalidomide	Given by PO

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-03-20
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study