Status:
COMPLETED
A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 intraven...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02268890
Start Date
December 1 2014
End Date
July 1 2015
Last Update
July 11 2016
Active Locations (6)
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1
Changhua, Taiwan
2
Kaohsiung City, Taiwan
3
Taichung, Taiwan
4
Tainan, Taiwan