A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) - NCT00473590-53226B (Clinical Trial 169962)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy169962.aspx
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| City: |
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Wauwatosa |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Multiple Myeloma |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Oncology Alliance - SC
Wauwatosa, WI 53226
United States
Primary Contact:
Jan De Bartolo
Email: jdebartolo@oncologyalliance.com
Phone: 414-778-4345
Secondary Contact:
Genentech Clinical Trial Support Line
Phone: 888-662-6728 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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