Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
NCT05344833 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-23
Summary
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Conditions
Interventions
- DRUG
-
Isatuximab
Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39.
- DRUG
-
Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.
Sponsors & Collaborators
-
Huntsman Cancer Institute
collaborator OTHER -
University of Illinois at Chicago
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-05
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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