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

NCT ID: NCT00473590

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-11-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

15 mg/kg administered by intravenous infusion

Bortezomib

Intervention Type: DRUG

1.3 mg/m\^2 administered by intravenous bolus injection

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.

Group Type: ACTIVE_COMPARATOR

Bortezomib

Intervention Type: DRUG

1.3 mg/m\^2 administered by intravenous bolus injection

placebo

Intervention Type: DRUG

Intravenous repeating dose

Interventions

Bevacizumab

15 mg/kg administered by intravenous infusion

Intervention Type: DRUG

Bortezomib

1.3 mg/m\^2 administered by intravenous bolus injection

Intervention Type: DRUG

placebo

Intravenous repeating dose

Intervention Type: DRUG

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
• New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
• Decreased left ventricular function at study entry
• History of myocardial infarction or unstable angina within 6 months prior to Day 1
• History of stroke or transient ischemic attack within 6 months prior to Day 1
• Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, including placement of a vascular access device within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
• Serious, non-healing wound, active ulcer, or untreated bone fracture (for pathologic bone fractures consistent with multiple myeloma, patients may be eligible if no treatment is planned)
• Albuminuria
• Known hypersensitivity to any component of bevacizumab
• Pregnancy (positive pregnancy test) or lactation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia (Ginny) Paton, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

AVF4064g

Identifier Type: -

Identifier Source: org_study_id