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

University of Arkansas

Status and phase: Terminated; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT00657553

100241

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Bortezomib/Treatment Arm

Active Comparator group

Description:

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

Treatment:

Drug: Bortezomib

Observation Arm (watchful waiting)

No Intervention group

Description:

monitor myeloma parameters every 3-6 months