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

NCT05346809 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAT7444
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphoma; Multiple Myeloma; Non-Hodgkin Lymphoma; Relapsed Hodgkin's Disease, Adult

Keywords

Stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Change in the total lymphocyte count

  Change in total lymphocyte count measured from blood sample

  Day 30

Secondary Outcomes (6)

• Number of Adverse Events

  Up to 1 year

• Percentage of participants with absolute lymphocyte count >500 cells/microliter

  Day 30

• CD8 and CD4 Subsets

  Up to 1 year

• Percentage of activated B and T regulatory cells

  Up to 1 year

• Percentage of activated helper and effector T cells

  Up to 1 year

Study Arms (2)

Isatuximab and Standard Procedures

EXPERIMENTAL

Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant

Drug: Isatuximab

Standard procedures

EXPERIMENTAL

Subjects will receive standard procedures for transplant.

Other: Standard Procedures

Interventions

Isatuximab DRUG

Isatuximab in IV form 10 mg/kg doses

Also known as: Sarclisa

Isatuximab and Standard Procedures

Standard Procedures OTHER

Standard procedures (standard of care) for transplant

Standard procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A) Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse.
• B) Relapsed/Refractory Hodgkin's disease
• C) Non-Hodgkin's Lymphomas as follows
• Relapsed/Refractory Diffuse large B cell lymphoma
• Relapsed/Refractory indolent or relapsed/refractory 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 or primary refractory disease
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Divaya Bhutani: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Divaya Bhutani

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: March 31, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

US (2)