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A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)
This study is currently recruiting participants.
Verified by Genentech, October 2008
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00473590
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: bevacizumab
Drug: placebo
Drug: bortezomib
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Bevacizumab Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment
Official Title: A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response and duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or loss to follow-up ] [ Designated as safety issue: No ]
  • Serious and selected adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: bortezomib
Intravenous repeating dose
2: Placebo Comparator Drug: placebo
Intravenous repeating dose
Drug: bortezomib
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473590

Contacts
Contact: Genentech Clinical Trial Support Line 888-662-6728

  Show 48 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Eric Hedrick, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: AVF4064g
Study First Received: May 14, 2007
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00473590  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Avastin
AMBER
Myeloma
Velcade

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Bevacizumab
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009