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
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