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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Bort, Dex, and Dox with ALCAR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00581919

NCI-2011-00516 (Registry Identifier)

HO04402

A534260 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

H-2004-0064 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Bort, Dex, and Dox with ALCAR

Experimental group

Treatment:

Drug: Bort, Dex, and Dox with ALCAR