A Phase 4 interventional study of Bortezomib in Multiple Myeloma, sponsored by Johnson & Johnson Taiwan Ltd. Completed at 6 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-07-11.
Sponsored by Johnson & Johnson Taiwan Ltd · Phase 4, Interventional, and Treatment
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).
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 18 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Johnson & Johnson Taiwan Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Also known as: Velcade
Initial Observed Plasma Drug Concentration (Co)
Initial concentration extrapolated to time zero (Co) will be evaluated.
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) will be observed.
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Area Under Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Time Point
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable time point, calculated by linear trapezoidal summation.
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC-Infinity)
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUClast + Clast/lamda(z), where Clast is the last measurable plasma concentration and lamda(z) is the terminal rate constant.
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Terminal Half-life (t1/2)
Terminal half-life, calculated by 0.693/lamda(z).
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Terminal rate constant (lamda[z])
Terminal rate constant estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Systemic clearance (CL)
Systemic clearance after IV dose, estimated by dividing the total administered dose by the plasma (AUC-Infinity).
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Apparent Volume of Distribution (Vd)
Apparent volume of distribution (Vd) based on the terminal phase after intravenous administration, calculated as Dose/(Lamda\[z\] \* AUC-Infinity).
Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Taiwan Ltd