Overview

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

Status:
Completed
Trial end date:
2020-03-09
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Lille
Collaborators:
Intergroupe Francophone du Myelome
Janssen, LP
Treatments:
Antibodies, Monoclonal
BB 1101
Daratumumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate