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

Sponsor:	University of Wisconsin, Madison
Information provided by (Responsible Party):	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:	Endpoint Classification: Safety/Efficacy Study 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

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 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 ]

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

Arms	Assigned Interventions
Experimental: Bortezomib, Dex and Dox with ALCAR	Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine Bortezomib, Dexamethasone, and Doxorubicin, 4-8 cycles of 21 days. ALCAR will also be given daily. Other Name: Velcade, cc-5013, ALCAR

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

Locations

United States, Wisconsin
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

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, Madison
ClinicalTrials.gov Identifier:	NCT00581919 History of Changes
Other Study ID Numbers:	HO04402
Study First Received:	December 19, 2007
Last Updated:	January 25, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

previously treated multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Acetylcarnitine

Carnitine
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
Bortezomib
Doxorubicin
BB 1101
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012