"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

Sponsor
Vejle Hospital
Study ID
NCT02419118
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Treatment of myeloma patients with Daratumumab
  • Lenalidomide — DRUG
    Treatment of myeloma patients
  • Dexamethasone — DRUG
    Treatment of myeloma patients

Study Details

Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

Key Dates

Start date
Jan 31, 2015
Status verified
Nov 2017
Primary completion
Oct 1, 2015
Completion
Oct 1, 2015

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dara len dex
    Daratumumab in combination with lenalidomide and dexamethasone
  • Active Comparator: Len dex
    Lenalidomide in combination with dexamethasone

Primary Outcome Measure

Response by IMWG criteria [ Time Frame: 4 weeks ]

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