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

Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma

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.

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.