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A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

NCT02541383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1085

Last updated 2025-04-13

Study results available
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Summary

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

Conditions

Interventions

DRUG

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)

Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation

DRUG

Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab

Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation

DRUG

Daratumumab

Daratumumab 16mg/kg every 8 weeks for 2 years

Sponsors & Collaborators

  • HOVON - Dutch Haemato-Oncology Association

    collaborator OTHER

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Intergroupe Francophone du Myelome

    lead NETWORK

Principal Investigators

  • Philippe Moreau, Pr · CHU Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-08-27
Completion
2023-09-01

Countries

  • Belgium
  • France
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541383 on ClinicalTrials.gov