NCT02268890

A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma

Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Johnson & Johnson Taiwan Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug enters and leaves the blood and tissues over time) characteristics of bortezomib when administered intravenously in Taiwanese participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

Detailed description

This is a Phase 4, single-arm, open-label (all knew the intervention of study), and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to explore the pharmacokinetics with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma. The study consists of a Screening phase and a bortezomib treatment phase with defined PK sample collection time points. Participants will receive bortezomib intravenous injection two times a week up to 2 weeks (on Days 1, 4, 8, and 11) and followed by a 10-day resting phase (Days 12 to 21) for 1 treatment cycle. Pharmacokinetics will primarily be evaluated. Participants' safety will be monitored throughout the study.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	Participants will receive a 1.3 milligram per square meter per dose (mg/m\^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-10-20
• Last updated: 2016-07-11

Locations

6 sites across 1 country: Taiwan