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

• ClinicalTrials.gov Identifier: NCT00581919
• Recruitment Status: Completed
• First Posted: December 28, 2007
• Results First Posted: August 24, 2016
• Last Update Posted: December 13, 2019
• Sponsor: University of Wisconsin, Madison
• Collaborator: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

United States, Wisconsin

Mercy Health Systems

Janesville, Wisconsin, United States

Gundersen Lutheran

La Crosse, 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

Millennium Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Natalie S Callander, MD; UWCCC

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00581919
• Other Study ID Numbers: HO04402; H-2004-0064 ( Other Identifier: Institutional Review Board ); A534260 ( Other Identifier: UW Madison ); SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison ); NCI-2011-00516 ( Registry Identifier: NCI Trial ID )
• First Posted: December 28, 2007
• Results First Posted: August 24, 2016
• Last Update Posted: December 13, 2019
• Last Verified: November 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; Acetylcarnitine; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients; Nootropic Agents