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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Isatuximab in IV form 10 mg/kg doses
Standard procedures (standard of care) for transplant
Karmanos Cancer Institute
Detroit, Michigan, United States
Columbia University
New York, New York, United States
Change in the total lymphocyte count
Change in total lymphocyte count measured from blood sample
Time frame: Day 30
Number of Adverse Events
The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 1 year
Percentage of participants with absolute lymphocyte count >500 cells/microliter
Percentage of participants with an absolute lymphocyte count of \>500 cells/microliter on Day 30 post transplant
Time frame: Day 30
CD8 and CD4 Subsets
Immune cell phenotyping ( cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) subsets) in the peripheral blood using flow cytometry based analysis
Time frame: Up to 1 year
Percentage of activated B and T regulatory cells
Percentage of activated B and T regulatory cells in the peripheral blood
Time frame: Up to 1 year
Percentage of activated helper and effector T cells
Percentage of activated helper and effector T cells in the peripheral blood
Time frame: Up to 1 year
Percentage of Natural Killer (NK) cells
Percentage of NK cells in the peripheral blood
Time frame: Up to 1 year
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