Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Overview[ - collapse ][ - ]
Purpose | Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily. |
---|---|
Condition | Multiple Myeloma |
Intervention | Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine |
Phase | Phase 2 |
Sponsor | University of Wisconsin, Madison |
Responsible Party | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier | NCT00581919 |
First Received | December 19, 2007 |
Last Updated | January 25, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 19, 2007 |
---|---|
Last Updated Date | January 25, 2012 |
Start Date | February 2004 |
Estimated Primary Completion Date | December 2010 |
Current Primary Outcome Measures | measurable serum or urine monoclonal protein [Time Frame: each cycle] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma |
---|---|
Official Title | Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma |
Brief Summary | Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily. |
Detailed Description | The primary objective of this study is to assess overall response rate to the treatment. Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Multiple Myeloma |
Intervention | Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine Bortezomib, Dexamethasone, and Doxorubicin, 4-8 cycles of 21 days. ALCAR will also be given daily. Other Names: Velcade, cc-5013, ALCAR |
Study Arm (s) | Experimental: Bortezomib, Dex and Dox with ALCAR |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 32 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | September 2010 |
Eligibility Criteria | Inclusion Criteria: - Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein. Exclusion Criteria: - Patients with previous doxorubicin treatment totaling 220 mg/m2 or more - LVEF less than 45% - Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be excluded - No history of seizures as ALCAR may lower the seizure threshold - Known HIV infection - Current pregnancy. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00581919 |
---|---|
Other Study ID Numbers | HO04402 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Wisconsin, Madison |
Study Sponsor | University of Wisconsin, Madison |
Collaborators | Not Provided |
Investigators | Principal Investigator: Natalie S Callander, MD UWCCC |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Mercy Health Systems | Janesville, Wisconsin, United States |
---|---|
Gundersen Lutheran | LaCrosse, Wisconsin, United States |
University of Wisconsin Cancer Center | Madison, Wisconsin, United States, 53792 |
Regional Cancer Center | Waukesha/Oconomowoc, Wisconsin, United States |
Aspirus Wausau Hospital, Aspirus Regional Cancer Center | Wausau, Wisconsin, United States |