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

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 19, 2007
Last updated: July 14, 2016
Last verified: July 2016
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: Bort, Dex, and Dox with ALCAR
Phase 2

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:

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

Primary Outcome Measures:
  • Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR [ Time Frame: each cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Off Study ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2004
Study Completion Date: July 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00581919

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
Principal Investigator: Natalie S Callander, MD UWCCC
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00581919     History of Changes
Other Study ID Numbers: HO04402 
Study First Received: December 19, 2007
Results First Received: July 14, 2016
Last Updated: July 14, 2016
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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics processed this record on October 20, 2016