Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
University of Illinois at Chicago
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)
Description
This is a phase II study where patients will undergo isatuximab and lenalidomide-based maintenance if they are MRD-positive after ASCT. Patients may have received equal to or less than 2 lines of induction therapy prior to ASCT. Patients will be enrolled at any time prior to ASCT or up to day 180 after ASCT.Patients will undergo disease reassessment per standard of care including BM examination and MRD testing by NGS at day 90 (+/- 30 days) of ASCT. All patients in MRD-negative (defined as 10-6) CR will be treated off study with lenalidomide monotherapy and all patients who are MRD-positive wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. 12\. Patients must be willing to take appropriate DVT prophylaxis, either aspirin, low molecular weight heparin, direct oral anticoagulants, or warfarin while receiving lenalidomide. Inclusion Criteria: 1. Age \> 18 years 2. Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell leuk…
Interventions
- DrugIsatuximab
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.
- DrugLenalidomide
Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.
Locations (2)
- University of Illinois at ChicagoChicago, Illinois
- Huntsman Cancer InstituteSalt Lake City, Utah