Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma ISATUXIMAB DURING STEM CELL TRANSPLANT

What's the purpose of this trial?

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. 

This trial is currently open and accepting patients.

What will happen during the trial?

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 outcomes of ASCT, however effective methods to improve upon immune reconstitution have not been developed and the use of novel immunomodulators remains relatively unexplored. In addition, numerous studies have demonstrated the profound impact of graft composition on transplant outcomes, but not a single prospective study has addressed this issue successfully. In this study, the investigators intend to test a novel double pronged method of changing the immune repertoire post ASCT by modifying graft composition and improving effector T cell recovery and function post ASCT. In this study, the investigators intend to generate new information on immune modulation post-ASCT. In addition, the CD38 antibodies have not been evaluated as therapy for B-cell non-Hodgkin Lymphoma (NHL). If this study shows significant immunomodulator activity of this approach, cluster of differentiation 38 (CD38) antibodies could be further evaluated in combination with ASCT in NHL.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Following diagnoses are eligible for inclusion in the study:
    • Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse.
    • Relapsed Hodgkin's disease C) Non-Hodgkin's Lymphomas as follows
      • Relapsed Diffuse large B cell lymphoma
      • Relapsed indolent or relapsed 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
  • 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 Criteria:

  • 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

Additional Trial Information

Phase 2

Enrollment: 39 patients (estimated)

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Trial Locations

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Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New York

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting
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