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

Multiple Myeloma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT05776979
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Muzzaffar Qazilbash, MD
• Phone: (713) 745-3458
• Email: mqazilba@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: August 17, 2023
• Completion date: December 31, 2027