RecruitingPhase 2NCT05346809

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

Sponsor

Divaya Bhutani

Enrollment

39 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called isatuximab (an antibody that targets cancer cells) during stem cell collection and transplant procedures in people with certain blood cancers. Stem cell transplants are used to help the immune system recover after high-dose chemotherapy, and this trial is exploring whether adding isatuximab improves outcomes. **You may be eligible if...** - You have multiple myeloma (a blood cancer) and are having a stem cell transplant as part of first-line or relapse treatment - You have relapsed or refractory Hodgkin's disease, diffuse large B-cell lymphoma, indolent B-cell lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma - This will be your first stem cell transplant - You are 18 or older with a life expectancy greater than 6 months **You may NOT be eligible if...** - You received a CD38 antibody treatment (like daratumumab) within the past 12 months - You are currently on another experimental drug or received one within the last 8 weeks - You have had severe allergic reactions to drugs similar to isatuximab - You have uncontrolled infections, heart failure, or significant psychiatric illness - You are pregnant, breastfeeding, or HIV-positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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