Using Isatuximab during stem cell collection and transplant for multiple myeloma and lymphoma patients
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
This study is testing if adding Isatuximab to the usual stem cell transplant process can help improve the immune system and recovery for patients with multiple myeloma or lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | Isatuximab |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Trial ID | NCT05346809 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Isatuximab on the immune system of patients with multiple myeloma or lymphoma following autologous stem cell transplantation (ASCT). Participants will be randomly assigned to either a control group receiving standard transplant procedures or an experimental group receiving Isatuximab alongside standard procedures. The goal is to determine if Isatuximab can enhance immune reconstitution and improve outcomes post-transplant. The study aims to provide insights into immune modulation and the potential use of CD38 antibodies in treating B-cell non-Hodgkin lymphoma.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with multiple myeloma or specific types of lymphoma undergoing their first autologous stem cell transplant.
Not a fit: Patients who have previously received a CD38 antibody within the last 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve immune recovery and reduce relapse rates in patients undergoing stem cell transplantation for multiple myeloma and lymphoma.
How similar studies have performed: While the use of immunomodulators in this context is relatively unexplored, other studies have shown promise in enhancing immune responses post-transplant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Patients undergoing first ASCT will be eligible for the study. 3. Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed. 4. Age ≥18 years 5. Life expectancy of greater than 6 months. Exclusion Criteria: 1. Previously exposure to a CD38 antibody during the last 12 months. 2. Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks. 3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab. 4. 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. 5. Pregnant and Lactating women 6. HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy
Where this trial is running
Detroit, Michigan and 1 other locations
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Divaya Bhutani — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.