Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT00574288
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Part 1: Daratumumab — DRUG
    First participant will receive intravenous (injection of a substance into a vein) 0.005 milligram per kilogram (mg/kg) (planned dose) infusion of daratumumab and other participants will receive different doses. The participants will receive 7 full infusions of daratumumab and 2 predose infusions every 2 weeks. The dose of daratumumab will be escalated sequentially and considering the safety and efficacy of dose in Part 1, dose for Part 2 of the study will be decided. A predose infusion of 10% of the full dose of daratumumab will be administered a day before the first 2 full infusions.
  • Part 2: Daratumumab — DRUG
    In Part 2, the participants will receive dose of daratumumab as determined in part 1 (16 mg/kg) of the study. Participants will receive 8 full infusions at weekly intervals followed by biweekly (every 2 weeks) infusions for 16 additional weeks and monthly infusions until disease progression or unmanageable toxicity, whichever comes first. Predose was dropped at some point in Part 2. A predose infusion of 10 mg daratumumab will be administered on the day before the first full infusion in select cohorts.
  • Methylprednisolone — OTHER
    Pre-dose: Participants (part 1) will receive methylprednisolone 80 mg intravenous (IV) injection 30 minutes to 2 hours before treatment. Participants (part 2) will receive 100 mg methylprednisolone IV 60 minutes to 2 hours before treatment; if a patient experiences no significant infusion-related reactions, the dose of methylprednisolone may be decreased to 50 mg after Visit 4. Post-dose: All participants (part 1) will receive 40 mg methylprednisolone orally on the first and the second day after all full infusions. During Part 2, all participants will receive 20-25 mg methylprednisolone orally or equivalent on the first and second days after all full-dose infusions.
  • Dexamethasone — OTHER
    Participants (Part 2) will receive 20 mg dexamethasone intravenous (IV) injection pre-dose, on the first and second days after every full-dose infusions.

Study Details

Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.

Key Dates

Start date
Mar 26, 2008
Status verified
Mar 2018
Primary completion
Jan 9, 2015
Completion
Apr 3, 2017

Study Design

Enrollment
104 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Daratumumab
  • Experimental: Dose Expansion: Daratumumab

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2) ]

Locations (1)

FacilityCityStateZIPSite coordinators
-BostonMassachusetts--

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By condition
Multiple myeloma
By specialty
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