Clinical Research Directory
Browse clinical research sites, groups, and studies.
2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy
Sponsor: University of Arkansas
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
Conditions
Interventions
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.
Thalidomide
Given by mouth at bedtime: days 1-4 of Induction
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
Daratumumab
Given by vein: day -1 of induction; days 1 and 8 of Immunological Consolidations; and day 1 of each Maintenance cycle
Cisplatin
Given by vein: days 1-4 (continuous infusion) of Induction
Adriamycin
Given by vein: days 1-4 (continuous infusion) of Induction
Cyclophosphamide
Given by vein: days 1-4 (continuous infusion) of Induction
Etoposide
Given by vein: days 1-4 (continuous infusion) of Induction
Melphalan
Given by vein: days -4 - -1 of Transplant(s)
ASCT
day 0 of Transplant(s)
Lenalidomide
Given by mouth: days 1-21 of alternating 3-month blocks during Maintenance
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