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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