RecruitingPhase 2NCT06140966

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


Sponsor

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

Enrollment

54 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests an intensive combination treatment — using daratumumab and carfilzomib together with other drugs, followed by a stem cell transplant — in people with newly diagnosed ultra high-risk multiple myeloma. Ultra high-risk myeloma includes tumors with multiple dangerous genetic changes, cancer growing outside the bone marrow, or cancer cells circulating in the blood. **You may be eligible if...** - You are between 18 and 70 years old - You have newly diagnosed multiple myeloma with ultra high-risk features: either two or more high-risk genetic changes, cancer growing outside the bone marrow, or leukemia-like spread of plasma cells in the blood - You have not received any prior systemic myeloma treatment (prior bisphosphonates and localized radiation are okay) - You are fit enough for intensive chemotherapy and a stem cell transplant - Your overall health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have already received systemic myeloma treatment - You are not healthy enough for a stem cell transplant - You do not have ultra high-risk features as defined by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDaratumumab

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.

DRUGCarfilzomib

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.

DRUGLenalidomide

Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.

DRUGDexamethasone

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

DRUGCisplatin

Given by vein: days 1-4 of each Induction cycle

DRUGepirubicin

Given by vein: days 1-4 of each Induction cycle

DRUGCyclophosphamide

Given by vein: days 1-4 of each Induction cycle

DRUGEtoposide

Given by vein: days 1-4 of each Induction cycle

DRUGMelphalan

Given by vein: day -1 of Transplant

PROCEDUREASCT

day 0 of Transplant

DRUGbortezomib

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06140966


Related Trials