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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Divaya Bhutani
Study ID
NCT05346809
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab — DRUG
    Isatuximab in IV form 10 mg/kg doses
  • Standard Procedures — OTHER
    Standard procedures (standard of care) for transplant

Study Details

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.

Key Dates

Start date
Mar 31, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Isatuximab and Standard Procedures
    Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant
  • Experimental: Standard procedures
    Subjects will receive standard procedures for transplant.

Primary Outcome Measure

Change in the total lymphocyte count [ Time Frame: Day 30 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Karmanos Cancer Institute
[email protected]
800-527-6266
Joseph P Uberti, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Divaya Bhutani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Karmanos Cancer Institute· Detroit, MIColumbia University· New York, NY

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