Pre and Post Transplant Elranatamab
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
What will happen during the trial?
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 elranatamab on hematopoietic progenitor cell mobilization and collection yield.
- To determine the safety and tolerability of elranatamab plus lenalidomide maintenance therapy after auto-HCT.
- To detect the MRD-negative rate before auto-HCT with in-vivo purging using elranatamab.
- To detect the MRD-negative rate after auto-HCT.
- To determine overall response rates as defined by the International Myeloma Working Group (IMWG).
- To determine the PFS and OS with elranatamab plus lenalidomide maintenance therapy after auto-HCT in participants with high-risk NDMM.
- To determine the PFS and OS in participants with high-risk NDMM who discontinue maintenance therapy after achieving CR plus sustained MRD-negative status.
- To determine the PFS and OS with elranatamab plus lena
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 2
- Enrollment
- 40 patients (estimated)
- Sponsors
- MD Anderson Cancer Center
- Collaborators
- Pfizer
- Tags
- Autologous Stem Cell Transplant, Bispecific Antibody, B-Cell Maturation Antigen (BCMA), CD3, High Risk, Post-Autologous Stem Cell Transplant, Pre-Autologous Stem Cell Transplant
- Trial Type
- Treatment
- Last Update
- 3 months ago
- SparkCures ID
- 1875
- NCT Identifier
- NCT06207799
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