NCT06207799

Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Multiple Myeloma
• Post-transplant MRD-guided Maintenance Therapy
• Pre-transplant Purging

Interventions

Type	Name	Description
DRUG	Elranatamab	Given by SC
DRUG	Lenalidomide	Given by PO
DRUG	Plerixafor	Given by SC
DRUG	Melphalan	Given by IV
DRUG	Busulfan	Given by PO
DRUG	G-CSF	Given by IV
PROCEDURE	Stem cell transplant	Given by IV

Timeline

• Start date: 2024-07-17
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2024-01-17
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study