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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581919
• Other study ID #: HO04402
• Secondary ID: H-2004-0064A5342
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: July 2013

Study information

• Verified date: November 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bort, Dex, and Dox with ALCAR
Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR	Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.; Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.; Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.	Every 21 days, up to 24 weeks
Secondary	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 7 years
Secondary	Progression-free Survival	Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.