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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 18, 2007 | ||||
| Last Updated Date | October 23, 2008 | ||||
| Start Date ICMJE | January 2004 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To learn if Bortezomib (Velcade) can help to control the disease in patients who have received a stem cell transplant from a related or unrelated donor and whose disease has either not gone into complete remission or whose disease has come back. [ Time Frame: 5 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To learn if Bortezomib (Velcade) can help to control the disease in patients who have received a stem cell transplant from a related or unrelated donor and whose disease has either not gone into complete remission or whose disease has come back. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00504634 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The safety of this treatment will also be studied. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma | ||||
| Official Title ICMJE | A Phase II Trial of Bortezomib (Velcade) After Allogenic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma | ||||
| Brief Summary | Primary Objective: 1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma. Secondary Objective 1. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation. |
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| Detailed Description | Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor cells and affects the way they divide. When cancer cells cannot divide, they die. You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1 cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician. Treatment evaluations will be under the supervision of the principal investigator. You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to treatment will be performed once a month, as well as blood tests to look at side effects of treatment, will be performed at least once a week and more frequently if medically necessary. You will be taken off study if the disease gets worse or intolerable side effects occur. You will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade) to see how you are doing. This is an investigational study. Bortezomib (velcade) is commercially available and indicated for the treatment of myeloma. A total of 28 patients will participate in this study. All will be enrolled at M. D. Anderson. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Multiple Myeloma | ||||
| Intervention ICMJE | Drug: Bortezomib | ||||
| Study Arms / Comparison Groups | Experimental: Bortezomib | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 28 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00504634 | ||||
| Responsible Party | Sergio A. Giralt, MD/Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2003-0751 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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