Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
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Purpose
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma |
- objective response rate
- progression-free survival
- overall survival
- Safety
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2004 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Upon determination of eligibility, patients will be receive:
- Bortezomib
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Multiple Myeloma
- Received no more than 2 previous treatment regimens for multiple Myeloma
- ECOG performance status 0, 1, or 2
- Serum creatinine < 2.0mg/dL
- calculated or measured creatinine clearance > 30ml/minute
- Measurable or evaluable disease
- Provide written informed consent prior to receiving protocol therapy.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Moderate or severe peripheral neuropathy
- Other serious medical conditions
- Other active malignancies
- history of treatment for other invasive cancers
- Women who are pregnant or lactating
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Contacts and Locations| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00193557 History of Changes |
| Other Study ID Numbers: | SCRI MM 06, 208538 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013