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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

NCT06140966 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-04-16

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2026-10-20
Completion
2027-10-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140966 on ClinicalTrials.gov