Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma an
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 syste
| Condition(s) | Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 gett |
| Who can participate | 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 allowe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Divaya Bhutani |
| Locations | Detroit, Michigan, United States; New York, New York, United States |
| Start date | 2023-03-31 |
| NCT ID | NCT05346809 |
| Official listing | https://clinicaltrials.gov/study/NCT05346809 |