RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-03-31
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05346809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Following diagnoses are eligible for inclusion in the study:
  2. * Relapsed/Refractory Diffuse large B cell lymphoma
  3. * Relapsed/Refractory indolent or relapsed/refractory transformed indolent B cell lymphomas as consolidation after second line therapy
  4. * Mantle Cell lymphoma as consolidation after first-line therapy
  5. * Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse or primary refractory disease
  6. 2. Patients undergoing first ASCT will be eligible for the study.
  7. 3. Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed.
  8. 4. Age ≥18 years
  9. 5. Life expectancy of greater than 6 months.
  1. 1. Previously exposure to a CD38 antibody during the last 12 months.
  2. 2. Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks.
  3. 3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.
  4. 4. 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.
  5. 5. Pregnant and Lactating women
  6. 6. HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy

Contacts and Locations

Study Contact

Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Divaya Bhutani
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Columbia University
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Divaya Bhutani

  • Divaya Bhutani, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-31
Study Completion Date2025-03

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Stem cell transplant

Additional Relevant MeSH Terms

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