Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

September 14, 2009

Start Date ^ICMJE

February 2004

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

measurable serum or urine monoclonal protein [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00581919 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma

Official Title ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Cancer Connect

800 622-8922

uwccc@uwccc.wisc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00581919

Responsible Party

Natalie Callander, University of Wisconsin

Study ID Numbers ^ICMJE

HO04402

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Natalie S Callander, MD

UWCCC

Information Provided By

University of Wisconsin, Madison

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP