Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment reduced: 39 → 8 participants
    • Primary and study completion pushed from Sep 2026 to Jul 2027
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v8
  2. Primary and study completion dates: Mar 2025 to Sep 2026v7
  3. Study sites: 1 to 2v6
  4. Primary and study completion dates pushed to Mar 2025
    • Start date: Feb 9, 2022 to Mar 31, 2023
    • Eligibility criteria expanded, about 4 words
    v5
  5. Start date changed from estimate of Aug 2022 to Feb 9, 2022v4
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  1. Start date: May 2022 to Aug 2022v3
  2. Interventions: Isatuximab (Drug) to Isatuximab (Drug), Standard Procedures (Other)v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05346809
Lead Sponsor Divaya Bhutani
Collaborators: Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
Related terms Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Multiple Myeloma
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov