Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT03184194
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma.

Key Dates

Start date
Feb 21, 2018
Status verified
May 2024
Primary completion
Jan 25, 2023
Completion
Jan 25, 2024

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab-daratumumab
    daratumumab 16 mg/kg: 8 times once weekly, then 8 times every 2 weeks; then every 4 weeks; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks
  • Experimental: Nivolumab-daratumumab with cylclophosphamide
    daratumumab 16 mg/kg: weekly for 8 weeks, then Q2W for 16 weeks, ten Q4W thereafter; nivolumab: 240 mg every 2 weeks during first 6 cycles, followed by 480 mg every 4 weeks; low-dose cyclophosphamide 50mg daily on days 1-28 of each 28-day cycle;

Primary Outcome Measure

overall response rate [ Time Frame: active treatment period up to 5 years ]

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