Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00581919
First received: December 19, 2007
Last updated: November 21, 2016
Last verified: November 2016
  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: Bort, Dex, and Dox with ALCAR
Phase 2

Study Type: Interventional
Study Design: 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: Every 21 days, up to 24 weeks ]

    Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.

    Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.

    Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.



Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 7 years ]
  • Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years. ]
    Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581919     History of Changes
Other Study ID Numbers: HO04402
Study First Received: December 19, 2007
Results First Received: July 14, 2016
Last Updated: November 21, 2016

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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Liposomal doxorubicin
Doxorubicin
Bortezomib
BB 1101
Acetylcarnitine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 21, 2017