Clinical trial NCT02268890: A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma
Official title: Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Bortezomib
Velcade
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 intravenously in Taiwanese participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

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 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

Primary outcomes:
measure: Initial Observed Plasma Drug Concentration (Co)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Area Under Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Time Point
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC-Infinity)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Terminal Half-life (t1/2)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Terminal rate constant (lamda[z])
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Systemic clearance (CL)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
measure: Apparent Volume of Distribution (Vd)
timeFrame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
References: