Multiple Myeloma Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

32

Study ID:

NCT00581919

Recruitment Status:

Completed

Sponsor:

University of Wisconsin, Madison

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There is 1 Location for this study

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Mercy Health Systems
Janesville Wisconsin, , United States
Gundersen Lutheran
La Crosse Wisconsin, , United States
University of Wisconsin Cancer Center
Madison Wisconsin, 53792, United States
Regional Cancer Center
Waukesha/Oconomowoc Wisconsin, , United States
Aspirus Wausau Hospital, Aspirus Regional Cancer Center
Wausau Wisconsin, , United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

32

Study ID:

NCT00581919

Recruitment Status:

Completed

Sponsor:


University of Wisconsin, Madison

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