NCT06140966

Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma

Detailed description

Survival outcomes for patients with newly diagnosed multiple myeloma (MM) have improved substantially in the past decades, due to the introduction of novel therapeutic strategies. Unfortunately, patients with ultra-high-risk MM, including "double-hit" MM, extramedullary MM (EMM), and primary plasma cell leukemia (pPCL), have a significantly worse prognosis and benefit less from current therapeutic strategies. This study aims to investigate whether a treatment regimen combining daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with autologous stem cell transplantation (ASCT) can improve the survival outcomes of newly diagnosed, transplant-eligible, ultra high-risk multiple myeloma patients. In the study, participants will receive induction therapy with 2-4 cycles of Dara-KRd-PACE, followed by ASCT, 4 cycles of Dara-KRd consolidation, and then maintenance with 12 cycles of Dara-Kd.

Conditions

• Multiple Myeloma
• Primary Plasma Cell Leukemia
• Extramedullary Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.
DRUG	Carfilzomib	Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.
DRUG	Lenalidomide	Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.
DRUG	Dexamethasone	Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance
DRUG	Cisplatin	Given by vein: days 1-4 of each Induction cycle
DRUG	epirubicin	Given by vein: days 1-4 of each Induction cycle
DRUG	Cyclophosphamide	Given by vein: days 1-4 of each Induction cycle
DRUG	Etoposide	Given by vein: days 1-4 of each Induction cycle
DRUG	Melphalan	Given by vein: day -1 of Transplant
PROCEDURE	ASCT	day 0 of Transplant
DRUG	bortezomib	given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy

Timeline

• Start date: 2023-10-20
• Primary completion: 2026-10-20
• Completion: 2027-10-20
• First posted: 2023-11-21
• Last updated: 2025-04-16

Locations

1 site across 1 country: China