Preemptive Strike With Bortezomib in Multiple Myeloma Patients

Study Overview
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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.

Official Title
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Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bortezomib/Treatment Arm<br>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 | Drug: Bortezomib<br>* 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<br>* Other names: Velcade;|
| No Intervention: Observation Arm (watchful waiting)<br>monitor myeloma parameters every 3-6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2 | The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates. Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication. | three years |