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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

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Stem cell transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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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