Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00581919|
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : August 24, 2016
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bort, Dex, and Dox with ALCAR||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2004|
|Primary Completion Date :||December 2010|
|Study Completion Date :||July 2013|
U.S. FDA Resources
|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|