NCT01801436

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

A Post Approval Commitment Study for Pharmacokinetic Analysis and Providing Expanded Access to Bortezomib (Velcade) for Patients With Multiple Myeloma Who Have Received at Least Two Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma in Taiwan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Johnson & Johnson Taiwan Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2013-02-28
• Last updated: 2013-05-16
• Results posted: 2013-05-16