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

NCT00473590 | Completed Phase 2 Results

• 1 other identifier: AVF4064g
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Keywords

Avastin; AMBER; Myeloma; Velcade

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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.

  From randomization to disease progression or death on study (up to 116 weeks).

Secondary Outcomes (5)

• Number of Participants With an Overall Response

  From randomization to the end of study (clinical cut-off; up to 116 weeks).

• 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).

Study Arms (2)

Bortezomib + bevacizumab

EXPERIMENTAL

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.

Drug: Bevacizumab; Drug: Bortezomib

Bortezomib + placebo

ACTIVE COMPARATOR

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.

Drug: Bortezomib; Drug: placebo

Interventions

Bevacizumab DRUG

15 mg/kg administered by intravenous infusion

Bortezomib + bevacizumab

Bortezomib DRUG

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

Bortezomib + bevacizumab; Bortezomib + placebo

placebo DRUG

Intravenous repeating dose

Bortezomib + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bevacizumab; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Virginia (Ginny) Paton, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 14, 2017
• Results First Posted: January 19, 2012

Record last verified: 2017-05