drugset / Trial / NCT05346809

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

NCT05346809

Phase 2 Recruiting 39 enrolled Divaya Bhutani Genzyme, a Sanofi Company · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-31
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Isatuximab Monoclonal antibody 10 mg/kg Intravenous