Study on Isatuximab During Stem Cell Collection and Transplant for Patients with Multiple Myeloma and Lymphoma
Sponsor: Divaya Bhutani
ClinicalTrials ID:NCT05346809
This clinical trial is exploring whether the drug Isatuximab can help the immune system fight cancer in patients with multiple myeloma or lymphoma after they undergo a stem cell transplant. Participants will be randomly assigned to receive either the standard transplant treatment or the standard treatment plus Isatuximab.
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Program Overview
The aim of this study is to find out if Isatuximab can help the immune system recover better after a stem cell transplant in patients with multiple myeloma or lymphoma. The study will have two groups: one group will receive the usual transplant treatment, and the other group will receive the usual treatment plus Isatuximab. Participants will be randomly assigned to one of these groups, with a 66% chance of receiving Isatuximab and a 33% chance of receiving the standard treatment only.
Description
Relapse after a stem cell transplant is a significant challenge in treating multiple myeloma and lymphoma. This study is investigating whether Isatuximab can improve the immune system's recovery after a transplant, potentially helping it fight cancer more effectively. The study will explore how Isatuximab affects the immune system and whether it can be a beneficial addition to the standard transplant procedure. If successful, this approach could lead to further research on using Isatuximab with stem cell transplants for certain types of lymphoma.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with:
- Multiple Myeloma using stem cell transplant after initial treatment or first relapse.
- Relapsed or difficult-to-treat Hodgkin's disease.
- Certain types of Non-Hodgkin's Lymphomas, including:
- Relapsed or difficult-to-treat Diffuse Large B Cell Lymphoma.
- Relapsed or difficult-to-treat indolent B Cell Lymphomas after second-line therapy.
- Mantle Cell Lymphoma after first-line therapy.
- Peripheral T Cell Lymphoma after first-line therapy or at relapse.
- Undergoing first stem cell transplant.
- Any previous cancer treatment except CD38 antibody in the last 12 months is allowed.
- Aged 18 years or older.
- Life expectancy of more than 6 months.
Exclusion Criteria
- Previous use of a CD38 antibody in the last 12 months.
- Currently receiving or recently received (within 8 weeks) any other experimental treatments.
- History of severe allergic reactions to Isatuximab or similar drugs.
- Uncontrolled health issues, such as ongoing infections, heart problems, or psychiatric conditions that could affect participation.
- Pregnant or breastfeeding women.
- HIV-positive status due to higher infection risk with immunosuppressive therapy.
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