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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Bort, Dex, and Dox with ALCAR

• Registration Number: NCT00581919
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2010-12
• Study Completion: 2013-07
• Results First Submitted: 2016-07-14
• Results First Submitted QC: 2016-07-14
• Results First Posted: 2016-08-24
• Status Verified: 2016-11
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bort, Dex, and Dox with ALCAR	Bort, Dex, and Dox with ALCAR	-

Primary Outcome Measures

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

Name	Time	Method
Overall Survival	From date of randomization until the date of death from any cause, assessed up to 7 years
Progression-free Survival	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.

Trial Locations

Locations (5)

University of Wisconsin Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Mercy Health Systems; 🇺🇸 Janesville, Wisconsin, United States

Gundersen Lutheran; 🇺🇸 La Crosse, Wisconsin, United States

Regional Cancer Center; 🇺🇸 Waukesha/Oconomowoc, Wisconsin, United States

Aspirus Wausau Hospital, Aspirus Regional Cancer Center; 🇺🇸 Wausau, Wisconsin, United States