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A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma

Information source: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Bortezomib (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Johnson & Johnson Taiwan Ltd

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

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).

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Initial Observed Plasma Drug Concentration (Co)

Maximum Observed Plasma Concentration (Cmax)

Area Under Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Time Point

Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC-Infinity)

Terminal Half-life (t1/2)

Terminal rate constant (lamda[z])

Systemic clearance (CL)

Apparent Volume of Distribution (Vd)

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of multiple myeloma based on the standard criteria

- Measurable, secretory multiple myeloma is defined as serum monoclonal immunoglobulin

(Ig) G of >= 10 gram per liters (g/L), serum monoclonal IgA or IgE greater than or equal to (>=) 5 g/L, serum monoclonal IgD >= 0. 5 g/L, or serum monoclonal IgM present (regardless of level), or urine M protein of >= 200 mg/24 hour at any time point of prior treatment

- Relapse or progression of myeloma following prior systemic antineoplastic therapy and

meet the indication which had been approved in the drug leaflet. Relapse is defined as: a) reappearance of measurable disease (as defined above) following complete response (CR); b) >= 25 percent (%) increase in serum or urine M-protein according to IMWG (International Myeloma Working group) criteria; c) development of new or worsening lytic bone disease; d) new plasmacytomas or >=50% increase in the longest dimension of an existing plasmacytoma; e) worsening hypercalcemia (corrected serum calcium >11. 5 milligram per deciliters [mg/dL-2. 8 millimoles per liters [mmol/L] due to multiple myeloma

- Karnofsky performance status >=70%

- Platelet count >=50 × 10^9 /L without transfusion support within 7 days before the

laboratory test Exclusion Criteria:

- More than 3 previous lines of therapy (separate lines of therapy are defined as

single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval)

- Peripheral neuropathy or neuropathic pain of National Cancer Institute-Common

Terminology Criteria for Adverse Events (NCI CTCAE) Version 4. 03 Grade >=2

- Any of the following within 3 weeks prior to enrollment in the study: antineoplastic

or experimental therapy, corticosteroid use above 10 mg/day (prednisone or equivalent), or plasmapheresis

- Any of the following within 2 weeks prior to enrollment in the study: radiation

therapy, major surgery (kyphoplasty is not considered major surgery)

- Prior malignancy other than multiple myeloma diagnosed or treated within the last 2

years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Changhua, Taiwan; Active, not recruiting

Kaohsiung, Taiwan; Active, not recruiting

Taichung City, Taiwan; Active, not recruiting

Tainan, Taiwan; Recruiting

Taipei, Taiwan; Active, not recruiting

Taipei, Taiwan; Recruiting

Taoyuan, Taiwan; Active, not recruiting

Additional Information

To learn how to participate in this trial please click here.

Starting date: December 2014
Last updated: July 31, 2015

Page last updated: August 23, 2015

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