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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

measurable serum or urine monoclonal protein

Outcome Time Frame:

each cycle

Safety Issue:

Yes

Principal Investigator

Natalie S Callander, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UWCCC

Authority:

United States: Institutional Review Board

Study ID:

HO04402

NCT ID:

NCT00581919

Start Date:

February 2004

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • previously treated multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Regional Cancer CenterEau Claire, Wisconsin  54701
University of Wisconsin Cancer CenterMadison, Wisconsin  53792
Gundersen LutheranLa Crosse, Wisconsin  54601
Mercy Health SystemsJanesville, Wisconsin  
Aspirus Wausau Hospital, Aspirus Regional Cancer CenterWausau, Wisconsin