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| Sponsor: | 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 |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Genentech Clinical Trial Support Line | 888-662-6728 |
Show 48 Study Locations| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Avastin AMBER Myeloma Velcade |
|
Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Bevacizumab Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Growth Inhibitors Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Growth Substances Bortezomib Vascular Diseases Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Multiple Myeloma Protease Inhibitors Neoplasms Lymphoproliferative Disorders Neoplasms, Plasma Cell |