A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Multiple Myeloma
- Sponsor
- Genentech, Inc.
- Enrollment
- 102
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Previously diagnosed with multiple myeloma
- •Relapsed or refractory multiple myeloma with disease progression following one to three prior treatment regimens
- •Measurable multiple myeloma disease
Exclusion Criteria
- •Grade ≥ 2 peripheral neuropathy
- •Use of corticosteroids within 21 days prior to Day 1
- •Use of other anti-myeloma therapy within 21 days prior to Day 1
- •Intolerance to bortezomib or compounds containing boron
- •Life expectancy of \< 12 weeks
- •Current, recent, or planned participation in an experimental drug study
- •Active malignancy other than multiple myeloma within 5 years before screening
- •Prior treatment with bevacizumab
- •Inadequately controlled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
Arms & Interventions
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.
Intervention: Bevacizumab
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.
Intervention: Bortezomib
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.
Intervention: Bortezomib
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.
Intervention: placebo
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: From randomization to disease progression or death on study (up to 116 weeks).
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.
Secondary Outcomes
- Percentage of Participants With an Overall Response(From randomization to the end of study (clinical cut-off; up to 116 weeks).)
- Duration of Response(From randomization to the end of study (clinical cut-off; up to 116 weeks).)
- Overall Survival (OS)(From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).)
- Number of Participants With Selected Adverse Events (AEs)(Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).)
- Number of Participants With an Overall Response(From randomization to the end of study (clinical cut-off; up to 116 weeks).)