NCT05346809

Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma

Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Divaya Bhutani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.

Detailed description

Relapse post-autologous stem cell transplantation (ASCT) remains a major challenge in the treatment of multiple myeloma (MM) and Lymphoma. The immune reconstitution post-ASCT has a major impact on the outcomes of ASCT, however effective methods to improve upon immune reconstitution have not been developed and the use of novel immunomodulators remains relatively unexplored. In addition, numerous studies have demonstrated the profound impact of graft composition on transplant outcomes, but not a single prospective study has addressed this issue successfully. In this study, the investigators intend to test a novel double pronged method of changing the immune repertoire post ASCT by modifying graft composition and improving effector T cell recovery and function post ASCT. In this study, the investigators intend to generate new information on immune modulation post-ASCT. In addition, the CD38 antibodies have not been evaluated as therapy for B-cell non-Hodgkin Lymphoma (NHL). If this study shows significant immunomodulator activity of this approach, cluster of differentiation 38 (CD38) antibodies could be further evaluated in combination with ASCT in NHL.

Conditions

• Lymphoma
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Relapsed Hodgkin's Disease, Adult

Interventions

Type	Name	Description
DRUG	Isatuximab	Isatuximab in IV form 10 mg/kg doses
OTHER	Standard Procedures	Standard procedures (standard of care) for transplant

Timeline

• Start date: 2023-03-31
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-04-26
• Last updated: 2025-06-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study