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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2013-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bort, Dex, and Dox with ALCAR

Group Type EXPERIMENTAL

Bort, Dex, and Dox with ALCAR

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Velcade, cc-5013, ALCAR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No