Preemptive Strike With Bortezomib in Multiple Myeloma Patients

NCT00657553 | Terminated Phase 3 Results DMC

• 1 other identifier: 100241
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bortezomib/Treatment Arm

ACTIVE COMPARATOR

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

Observation Arm (watchful waiting)

NO INTERVENTION

monitor myeloma parameters every 3-6 months

Interventions

Bortezomib 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

Also known as: Velcade

Bortezomib/Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

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

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Nathan M. Petty
• Organization: University of Arkansas for Medical Sciences, Myeloma Institute

pettynathanm@uams.edu

501-569-6990

Study Officials

• Bart Barlogie, MD, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 20, 2017
• Results First Posted: July 12, 2011

Record last verified: 2017-10

Locations

US (1)