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

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ClinicalTrials.gov Identifier: NCT05346809
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : May 3, 2022
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Divaya Bhutani, Columbia University

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 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.

Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma Non-Hodgkin Lymphoma Relapsed Hodgkin's Disease, Adult Drug: Isatuximab Other: Standard Procedures Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Isatuximab and Standard Procedures
Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant
Drug: Isatuximab
Isatuximab in IV form 10 mg/kg doses
Other Name: Sarclisa

Experimental: Standard procedures
Subjects will receive standard procedures for transplant.
Other: Standard Procedures
Standard procedures (standard of care) for transplant




Primary Outcome Measures :
  1. Change in the total lymphocyte count [ Time Frame: Day 30 ]
    Change in total lymphocyte count measured from blood sample


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: Up to 1 year ]
    The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  2. Percentage of participants with absolute lymphocyte count >500 cells/microliter [ Time Frame: Day 30 ]
    Percentage of participants with an absolute lymphocyte count of >500 cells/microliter on Day 30 post transplant

  3. CD8 and CD4 Subsets [ Time Frame: Up to 1 year ]
    Immune cell phenotyping ( cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) subsets) in the peripheral blood using flow cytometry based analysis

  4. Percentage of activated B and T regulatory cells [ Time Frame: Up to 1 year ]
    Percentage of activated B and T regulatory cells in the peripheral blood

  5. Percentage of activated helper and effector T cells [ Time Frame: Up to 1 year ]
    Percentage of activated helper and effector T cells in the peripheral blood

  6. Percentage of Natural Killer (NK) cells [ Time Frame: Up to 1 year ]
    Percentage of NK cells in the peripheral blood



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05346809


Contacts
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Contact: Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Locations
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United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Research Nurse Navigator    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
Principal Investigator: Divaya Bhutani, MD         
Sponsors and Collaborators
Divaya Bhutani
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Divaya Bhutani Columbia University
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Responsible Party: Divaya Bhutani, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT05346809    
Other Study ID Numbers: AAAT7444
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Divaya Bhutani, Columbia University:
Stem cell transplant
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders