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RECRUITING
NCT06140966
PHASE2

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

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

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-10-20

Completion Date

2027-10-20

Last Updated

2025-04-16

Healthy Volunteers

No

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

Locations (1)

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

Wuhan, Hubei, China