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.
ConditionMultiple Myeloma
InterventionDrug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine
PhasePhase 2
SponsorUniversity of Wisconsin, Madison
Responsible PartyUniversity of Wisconsin, Madison
ClinicalTrials.gov IdentifierNCT00581919
First ReceivedDecember 19, 2007
Last UpdatedJanuary 25, 2012
Last verifiedJanuary 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 19, 2007
Last Updated DateJanuary 25, 2012
Start DateFebruary 2004
Estimated Primary Completion DateDecember 2010
Current Primary Outcome Measuresmeasurable serum or urine monoclonal protein [Time Frame: each cycle] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePh 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
Official TitlePhase 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 TypeInterventional
Study PhasePhase 2
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionMultiple Myeloma
InterventionDrug: 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 StatusCompleted
Estimated Enrollment32
Estimated Completion DateDecember 2010
Estimated Primary Completion DateSeptember 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00581919
Other Study ID NumbersHO04402
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Wisconsin, Madison
Study SponsorUniversity of Wisconsin, Madison
CollaboratorsNot Provided
Investigators Principal Investigator: Natalie S Callander, MD UWCCC
Verification DateJanuary 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