Overview

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

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
Acetylcarnitine
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
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.