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

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00581919

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	Intervention	Phase
Multiple Myeloma	Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Bortezomib Carnitine Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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

Estimated Enrollment:	32
Study Start Date:	February 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bortezomib, Dex and Dox with ALCAR: Experimental	Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine Bortezomib, Dexamethasone, and Doxorubicin, 4-8 cycles of 21 days. ALCAR will also be given 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581919

Contacts

Contact: Cancer Connect

800 622-8922

uwccc@uwccc.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Natalie S Callander, MD 608-263-1836 nsc@medicine.wisc.edu
Aspirus Wausau Hospital, Aspirus Regional Cancer Center	Recruiting
Wausau, Wisconsin, United States
Principal Investigator: Harish Ahuja, MD
Fox Valley Hematology and Oncology Associates	Recruiting
Appleton, Wisconsin, United States
Regional Cancer Center	Recruiting
Waukesha/Oconomowoc, Wisconsin, United States
Principal Investigator: Richard Hansen, MD
Mercy Health Systems	Recruiting
Janesville, Wisconsin, United States
Principal Investigator: Emily Robinson, MD
Gundersen Lutheran	Recruiting
LaCrosse, Wisconsin, United States
Principal Investigator: Alcee Jumonville, MD
Sub-Investigator: Vikram Chand, MD

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Natalie S Callander, MD

UWCCC

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Natalie Callander )
Study ID Numbers:	HO04402
Study First Received:	December 19, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00581919 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

previously treated multiple myeloma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Antibiotics, Antineoplastic
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Vitamins
Therapeutic Uses

Cardiovascular Diseases
Micronutrients
Dexamethasone acetate
Acetylcarnitine
Nootropic Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Vitamin B Complex
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Bortezomib
Gastrointestinal Agents
Vascular Diseases

ClinicalTrials.gov processed this record on November 09, 2009