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Preemptive Strike With Bortezomib in Multiple Myeloma Patients

NCT ID: NCT00657553

Last Updated: 2017-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Detailed Description

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Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bortezomib/Treatment Arm

Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks

Observation Arm (watchful waiting)

monitor myeloma parameters every 3-6 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bortezomib

Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks

Intervention Type DRUG

Other Intervention Names

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Velcade

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation.
* Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria
* Previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment
* Previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment.
* Adequate renal function
* Signed informed consent
* Female subject is post-menopausal or willing to use acceptable birth control
* Male subjects agree to use acceptable method of contraceptive

Exclusion Criteria

* Hypersensitivity to Bortezomib, boron, or mannitol
* Female subject is pregnant or breastfeeding
* Experienced myocardial infraction within 6 months prior to enrollment
* Received other investigational new drugs within 14 days before enrollment
* Received any anti-myeloma therapy within 14 days
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Diagnosed or treated for another malignancy within 3 years of enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bart Barlogie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

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University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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100241

Identifier Type: -

Identifier Source: org_study_id