NCT03004287

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Past studies conducted at the Myeloma Institute and at other institutions have shown that many patients with high-risk disease (as determined by gene array studies - studies that look at specific genes using special equipment) tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. The Total Therapy approach to treatment carried out at the Myeloma Institute where multiple chemotherapy agents are given as induction followed by a stem cell transplant, post-transplant consolidation, and maintenance therapy has proven to be the best available treatment strategy. However, the availability of new treatments that work in different ways offers the possibility of improving the effectiveness of Total Therapy treatment while potentially reducing the number of side effects patients' experience. Daratumumab is a human monoclonal antibody or protein drug. It recognizes a specific protein, CD38, which is found at high levels on multiple myeloma cells. An antibody is something that finds and kills foreign objects in your body, in this case, myeloma cells. The other drugs that will be used in the study treatment regimen include carfilzomib or bortezomib, thalidomide, lenalidomide, dexamethasone, cisplatin, adriamycin, cyclophosphamide, etoposide, lenalidomide and dexamethasone.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2016-12-28
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study