Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR [ Time Frame: Every 21 days, up to 24 weeks ]
Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.
Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.
Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.
- Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 7 years ]
- Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years. ]Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.
|Study Start Date:||February 2004|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Bort, Dex, and Dox with ALCAR||
Drug: Bort, Dex, and Dox with ALCAR
Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
Other Name: Velcade, cc-5013, ALCAR
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581919
|United States, Wisconsin|
|Mercy Health Systems|
|Janesville, Wisconsin, United States|
|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|
|Principal Investigator:||Natalie S Callander, MD||UWCCC|