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Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma

NCT02626481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-07

No results posted yet for this study

Summary

This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.

There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.

Conditions

Interventions

DRUG

Daratumumab

patients treated with Daratumumab (16 mg/kg) and Dexamethasone (40 or 20 mg regarding age of patient)

DRUG

Dexamethasone

patients treated with Dexamethasone (40 or 20 mg regarding age of patient)

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Intergroupe Francophone du Myelome

    collaborator NETWORK

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Thierry Facon, MD, PhD · University Hospital, Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-28
Primary Completion
2020-03-09
Completion
2020-03-09

Countries

  • Belgium
  • France

Study Locations

More Related Trials

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 NCT02626481 on ClinicalTrials.gov