Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Daratumumab; VELCADE (Bortezomib); Dexamethasone
Intervention description: Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.; VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.; Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.
Intervention MeSH terms: Dexamethasone; Bortezomib; Daratumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Plasmacytoma; Refractory Multiple Myeloma; Relapsed Multiple Myeloma; Daratumumab; VELCADE

Summary:

      The purpose of this study is to assess the effects of administration of daratumumab when
      combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and
      dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have had documented multiple myeloma

          -  Must have received at least 1 prior line of therapy for multiple myeloma

          -  Must have had documented evidence of progressive disease as defined based on
             Investigator's determination of response of International Myeloma Working Group (IMWG)
             criteria on or after their last regimen

          -  Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

          -  Must have achieved a response (partial response [PR] or better based on investigator's
             determination of response by the IMWG criteria) to at least 1 prior regimen in the
             past

        Exclusion Criteria:

          -  Has received daratumumab or other anti-CD38 therapies previously

          -  Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression
             of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy
             or another PI therapy, like ixazomib and carfilzomib

          -  Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE
             treatment)

          -  Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of
             the treatment, whichever is longer, before the date of randomization. The only
             exception is emergency use of a short course of corticosteroids (equivalent of
             dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment.
             A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is
             provided in the Site Investigational Product Procedures Manual (IPPM).

          -  Has a history of malignancy (other than multiple myeloma) within 3 years before the
             date of randomization

          -  Has any concurrent medical condition or disease (eg, active systemic infection) that
             is likely to interfere with study procedures