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ACTIVE NOT RECRUITING
NCT03004287
PHASE2

2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy

Sponsor: University of Arkansas

View on ClinicalTrials.gov

Summary

This study will assess whether adding one of the newest multiple myeloma therapies, daratumumab, into the Total Therapy approach helps patients live longer with fewer side effects

Official title: 2015-12: A Phase II Study Exploring the Use of Early and Late Consolidation/Maintenance With Anti-CD38 (Protein) Monoclonal Antibody to Improve Progression Free Survival in Patients With Newly Diagnosed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2017-07-01

Completion Date

2027-10

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

Carfilzomib

Given by vein: days 1 and 2 of Induction; days 1, 8, 15, and 22 of Consolidation 1; and days 1, 8, 15, and 22 of alternating 3-month blocks during Maintenance.

DRUG

Thalidomide

Given by mouth at bedtime: days 1-4 of Induction

DRUG

Dexamethasone

Given by mouth or by vein: days 1-4 of Induction; days -4 - -1 of Transplant(s); and days 1, 8, 15, and 22 of every cycle during Maintenance

DRUG

Daratumumab

Given by vein: day -1 of induction; days 1 and 8 of Immunological Consolidations; and day 1 of each Maintenance cycle

DRUG

Cisplatin

Given by vein: days 1-4 (continuous infusion) of Induction

DRUG

Adriamycin

Given by vein: days 1-4 (continuous infusion) of Induction

DRUG

Cyclophosphamide

Given by vein: days 1-4 (continuous infusion) of Induction

DRUG

Etoposide

Given by vein: days 1-4 (continuous infusion) of Induction

DRUG

Melphalan

Given by vein: days -4 - -1 of Transplant(s)

PROCEDURE

ASCT

day 0 of Transplant(s)

DRUG

Lenalidomide

Given by mouth: days 1-21 of alternating 3-month blocks during Maintenance

DRUG

Bortezomib

Given by vein or subcutaneous injection: may be substituted for carfilzomib throughout the study regimen at the discretion of the treating physician

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States