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

NCT ID: NCT00581919

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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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.

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

Keywords

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previously treated 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

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie S Callander, MD

Role: PRINCIPAL_INVESTIGATOR

UWCCC

Locations

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Mercy Health Systems

Janesville, Wisconsin, United States

Site Status

Gundersen Lutheran

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Cancer Center

Madison, Wisconsin, United States

Site Status

Regional Cancer Center

Waukesha/Oconomowoc, Wisconsin, United States

Site Status

Aspirus Wausau Hospital, Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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H-2004-0064

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00516

Identifier Type: REGISTRY

Identifier Source: secondary_id

HO04402

Identifier Type: -

Identifier Source: org_study_id