Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
M.D. Anderson Cancer Center
Summary
To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.
Description
Primary Objectives * To determine the overall proportion of high-risk MM participants achieving sustained MRD-negative CR status after the completion of the treatment plan including in-vivo purging with elranatamab, auto-HCT, and post-transplant maintenance therapy. Sustained MRD-negativity is defined as MRD-negative status in two assessments, at least 1-year apart, without any MRD-positive status in between. * To determine the proportion of patients with clonal plasma cell negative autograft collection in participants with high-risk MM. Secondary Objectives * To assess the impact of elrana…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Transplant eligible patients with newly diagnosed multiple myeloma (NDMM). 2. High-risk multiple myeloma\* 3. Participants with disease response ≥ PR to induction therapy 4. Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible. 5. Karnofsky performance status ≥70 (Appendix A). 6. Adequate liver function (total bilirubin ≤1.5X ULN; ALT ≤2.5 X ULN) 7. Estimated creatinine clearance ≥40 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, estimated glomerular filtration rate (Modification of Diet in Renal Disease \[MDRD\]), or Chronic Kidney D…
Interventions
- DrugElranatamab
Given by SC
- DrugLenalidomide
Given by PO
- DrugPlerixafor
Given by SC
- DrugMelphalan
Given by IV
- DrugBusulfan
Given by PO
- DrugG-CSF
Given by IV
- ProcedureStem cell transplant
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas