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

Phase 2CompletedNCT00581919

University of Wisconsin, Madison32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Bort, Dex, and Dox with ALCARDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Mercy Health Systems

Janesville, Wisconsin, United States

Gundersen Lutheran

La Crosse, Wisconsin, United States

University of Wisconsin Cancer Center

Madison, Wisconsin, United States

Regional Cancer Center

Waukesha/Oconomowoc, Wisconsin, United States

Outcomes

Primary Outcomes

Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR

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.

Time frame: Every 21 days, up to 24 weeks

Secondary Outcomes

Overall Survival

Time frame: From date of randomization until the date of death from any cause, assessed up to 7 years

Progression-free Survival

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.

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.

Data from ClinicalTrials.gov

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