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

Sponsor
University Hospital, Lille
Study ID
NCT02626481
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 28, 2015
Status verified
Mar 2021
Primary completion
Mar 9, 2020
Completion
Mar 9, 2020

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of best Overall Response using the IMWG response criteria [ Time Frame: 60 months ]

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