A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma
A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma
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.
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