NCT06879379

KPD Consolidation After ASCT in NDMM Patients

A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.

Detailed description

Multiple myeloma (MM) is a malignancy characterized by abnormal proliferation of plasma cells, leading to organ damage and poor prognosis. Despite advances in treatment, including autologous stem cell transplantation (ASCT), the disease remains incurable for most patients. Post-transplant consolidation and maintenance therapies have emerged as critical strategies to deepen remission and prolong progression-free survival (PFS). However, the role of consolidation therapy remains debated. This study aims to clarify whether KPD consolidation therapy after ASCT provides additional benefits compared to direct maintenance therapy.

Conditions

• Multiple Myeloma, Newly Diagnosed

Interventions

Type	Name	Description
DRUG	KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation	After post-transplant randomization, patients will receive either KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation then maintenance or no consolidation and maintenance.

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

3 sites across 1 country: China