Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
Primary Purpose
Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Isatuximab
Standard Procedures
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Stem cell transplant
Eligibility Criteria
Inclusion Criteria:
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
- 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
Sites / Locations
- Columbia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Isatuximab and Standard Procedures
Standard procedures
Arm Description
Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant
Subjects will receive standard procedures for transplant.
Outcomes
Primary Outcome Measures
Change in the total lymphocyte count
Change in total lymphocyte count measured from blood sample
Secondary Outcome Measures
Number of Adverse Events
The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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
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
Percentage of activated B and T regulatory cells
Percentage of activated B and T regulatory cells in the peripheral blood
Percentage of activated helper and effector T cells
Percentage of activated helper and effector T cells in the peripheral blood
Percentage of Natural Killer (NK) cells
Percentage of NK cells in the peripheral blood
Full Information
NCT ID
NCT05346809
First Posted
April 20, 2022
Last Updated
October 26, 2022
Sponsor
Divaya Bhutani
Collaborators
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT05346809
Brief Title
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Divaya Bhutani
Collaborators
Genzyme, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
Keywords
Stem cell transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Isatuximab and Standard Procedures
Arm Type
Experimental
Arm Description
Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant
Arm Title
Standard procedures
Arm Type
Experimental
Arm Description
Subjects will receive standard procedures for transplant.
Intervention Type
Drug
Intervention Name(s)
Isatuximab
Other Intervention Name(s)
Sarclisa
Intervention Description
Isatuximab in IV form 10 mg/kg doses
Intervention Type
Other
Intervention Name(s)
Standard Procedures
Intervention Description
Standard procedures (standard of care) for transplant
Primary Outcome Measure Information:
Title
Change in the total lymphocyte count
Description
Change in total lymphocyte count measured from blood sample
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
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
Title
Percentage of participants with absolute lymphocyte count >500 cells/microliter
Description
Percentage of participants with an absolute lymphocyte count of >500 cells/microliter on Day 30 post transplant
Time Frame
Day 30
Title
CD8 and CD4 Subsets
Description
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
Title
Percentage of activated B and T regulatory cells
Description
Percentage of activated B and T regulatory cells in the peripheral blood
Time Frame
Up to 1 year
Title
Percentage of activated helper and effector T cells
Description
Percentage of activated helper and effector T cells in the peripheral blood
Time Frame
Up to 1 year
Title
Percentage of Natural Killer (NK) cells
Description
Percentage of NK cells in the peripheral blood
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Nurse Navigator
Phone
212-342-5162
Email
cancerclinicaltrials@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Divaya Bhutani
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Nurse Navigator
Phone
212-342-5162
Email
cancerclinicaltrials@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Divaya Bhutani, MD
12. IPD Sharing Statement
Learn more about this trial
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
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