Status:
RECRUITING
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
Lead Sponsor:
Divaya Bhutani
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 investigato...
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...
Eligibility Criteria
Inclusion
- Following diagnoses are eligible for inclusion in the study:
- A) Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse.
- B) Relapsed/Refractory Hodgkin's disease
- C) Non-Hodgkin's Lymphomas as follows
- Relapsed/Refractory Diffuse large B cell lymphoma
- Relapsed/Refractory indolent or relapsed/refractory transformed indolent B cell lymphomas as consolidation after second line therapy
- Mantle Cell lymphoma as consolidation after first-line therapy
- Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse or primary refractory disease
- Patients undergoing first ASCT will be eligible for the study.
- Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed.
- Age ≥18 years
- Life expectancy of greater than 6 months.
Exclusion
- Previously exposure to a CD38 antibody during the last 12 months.
- Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks.
- History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and Lactating women
- HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05346809
Start Date
March 31 2023
End Date
September 1 2026
Last Update
June 8 2025
Active Locations (2)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
Columbia University
New York, New York, United States, 10032