Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05346809

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

Led by Divaya Bhutani · Updated on 2025-06-08

39

Participants Needed

2

Research Sites

178 weeks

Total Duration

On this page

Sponsors

D

Divaya Bhutani

Lead Sponsor

G

Genzyme, a Sanofi Company

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple myeloma, relapsed/refractory Hodgkin's disease, or specific types of relapsed/refractory non-Hodgkin's lymphoma including diffuse large B cell lymphoma, indolent B cell lymphomas, mantle cell lymphoma, or peripheral T cell lymphoma
  • Undergoing first autologous stem cell transplant
  • Any prior therapy allowed except CD38 antibody treatment within the last 12 months
  • Age 18 years or older
  • Life expectancy greater than 6 months
Not Eligible

You will not qualify if you...

  • Received CD38 antibody treatment within the last 12 months
  • Receiving other investigational agents currently or within the last 8 weeks
  • History of severe allergic reactions to compounds similar to Isatuximab
  • Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
  • Pregnant or lactating women
  • HIV positive status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

2

Columbia University

New York, New York, United States, 10032

Actively Recruiting

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Research Team

R

Research Nurse Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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