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

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

Conditions

• Multiple Myeloma

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

Sponsors & Collaborators

• Janssen, LP

  collaborator INDUSTRY

• University of Arkansas

  lead OTHER

Principal Investigators

• Frits van Rhee, MD · University of Arkansas for Medical Science-Myeloma Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2026-10-31

Completion

2027-10-31

FDA Drug

Yes

Countries

• United States

Study Locations