NCT06140966View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

October 20, 2026

Study Completion Date

October 20, 2027

Conditions
Multiple MyelomaPrimary Plasma Cell LeukemiaExtramedullary Multiple Myeloma
Interventions
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

Trial Locations (1)

Unknown

RECRUITING

Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER