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| ID | Type | Description | Link |
|---|---|---|---|
| 26866138MMY4073 | Other Identifier | Johnson & Johnson Taiwan Ltd. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial Observed Plasma Drug Concentration (Co) | Initial concentration extrapolated to time zero (Co) will be evaluated. | 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. | 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. | 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. | 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). | 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. | 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua | Taiwan | |||||
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| Label | URL |
|---|---|
| Pharmacokinetic Study of Bortezomib (VELCADE®) Administered Intravenously in Taiwanese Patients with Multiple Myeloma - A Post Approval Commitment Study | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Systemic clearance (CL) | Systemic clearance after IV dose, estimated by dividing the total administered dose by the plasma (AUC-Infinity). | 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). | 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14 |
| Kaohsiung City |
| Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |