A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma

NCT ID: NCT01801436

Last Updated: 2013-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-04-30

Brief Summary

The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

Detailed Description

This is an open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who have received at least 2 previous lines of therapy (medicine or medical care given to a participant for a disease or condition) and are refractory (not responding to treatment) to or have relapsed (the return of a medical problem) after their last therapy. Eligible participants will receive bortezomib 1.3 milligram (mg) per meter square (m^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. Blood samples for PK assessment will be collected on specified time points of Day 1, Day 8, and Day 11 of Cycle 1. Efficacy of the participants will primarily be evaluated by recording 'response to treatment' and 'Karnofsky Performance Status'. Participants' safety will be monitored throughout the study.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bortezomib

Bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.

Interventions

Bortezomib

Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.

Intervention Type: DRUG

Other Intervention Names

VELCADE

Eligibility Criteria

Inclusion Criteria

• Participants previously diagnosed with multiple myeloma based on standard criteria
• Participant has received at least 2 previous lines of therapy for multiple myeloma and, in the Investigator's opinion, currently requires therapy because of relapsed (the return of a medical problem) or progressive disease
• Female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from Screening through the Final Visit
• If male, the participant agrees to use an acceptable barrier method for contraception from Screening through the Final Visit
• Participant has a Karnofsky performance status classifies participants as to their functional impairment and is used to compare effectiveness of different therapies and to assess the prognosis [outlook, probable outcomes] in individual participants) greater than 60

Exclusion Criteria

• If the participant received bortezomib in a previous trial, the Participants' best response to bortezomib must be progressive disease
• If the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events
• Participants who have received nitrosoureas within 6 weeks or any other chemotherapy (treatment of disease, usually cancer, by chemical agents) within 3 weeks before enrollment
• Participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment
• Human Immunodeficiency Virus (HIV - a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person)-positive or hepatitis-B surface antigen-positive participants or participants with known active hepatitis-C infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Taiwan Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Taiwan Ltd Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Taiwan Ltd

Other Identifiers

26866138MMY3014

Identifier Type: -

Identifier Source: secondary_id

CR013843

Identifier Type: -

Identifier Source: org_study_id