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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00473590 |
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 |
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 |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Genentech Clinical Trial Support Line | 888-662-6728 |
Study Director: | Eric Hedrick, M.D. | Genentech |
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 |
Avastin AMBER Myeloma Velcade |
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 |
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 |