A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)

Sponsor
Genentech, Inc.
Study ID
NCT00473590
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg administered by intravenous infusion
  • Bortezomib — DRUG
    1.3 mg/m\^2 administered by intravenous bolus injection
  • placebo — DRUG
    Intravenous repeating dose

Study Details

This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma.

Key Dates

First listed
May 15, 2007
Start date
Jun 30, 2007
Status verified
May 2017
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

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

Arms

  • Experimental: Bortezomib + bevacizumab
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
  • Active Comparator: Bortezomib + placebo
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From randomization to disease progression or death on study (up to 116 weeks). ]

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