Preemptive Strike With Bortezomib in Multiple Myeloma Patients (2007-77)

October 17, 2017 updated by: University of Arkansas

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Other Names:
  • Velcade
No Intervention: Observation Arm (watchful waiting)
monitor myeloma parameters every 3-6 months

What is the study measuring?

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
Time Frame: three years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Bart Barlogie, MD, PhD, UAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Bortezomib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe