Working... Menu
Trial record 36 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581919
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : August 24, 2016
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bort, Dex, and Dox with ALCAR Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 7 years ]
  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581919

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Natalie S Callander, MD UWCCC

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison Identifier: NCT00581919     History of Changes
Other Study ID Numbers: HO04402
First Posted: December 28, 2007    Key Record Dates
Results First Posted: August 24, 2016
Last Update Posted: January 13, 2017
Last Verified: November 2016

Keywords provided by University of Wisconsin, Madison:
previously treated multiple myeloma

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemostatic Disorders
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists