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A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Bortezomib

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Bortezomib, Velcade

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib

Arm Description

Participants will receive a 1.3 milligram per square meter per dose (mg/m^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.

Outcomes

Primary Outcome Measures

Initial Observed Plasma Drug Concentration (Co)

Initial concentration extrapolated to time zero (Co) will be evaluated.

Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration (Cmax) will be observed.

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

Area under the plasma concentration-time curve from time 0 to the time of last quantifiable time point, calculated by linear trapezoidal summation.

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

Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUClast + Clast/lamda(z), where Clast is the last measurable plasma concentration and lamda(z) is the terminal rate constant.

Terminal Half-life (t1/2)

Terminal half-life, calculated by 0.693/lamda(z).

Terminal rate constant (lamda[z])

Terminal rate constant estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.

Systemic clearance (CL)

Systemic clearance after IV dose, estimated by dividing the total administered dose by the plasma (AUC-Infinity).

Apparent Volume of Distribution (Vd)

Apparent volume of distribution (Vd) based on the terminal phase after intravenous administration, calculated as Dose/(Lamda[z] * AUC-Infinity).

Secondary Outcome Measures

Full Information

NCT ID

NCT02268890

First Posted

October 15, 2014

Last Updated

July 8, 2016

Sponsor

Johnson & Johnson Taiwan Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02268890

Brief Title

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

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Taiwan Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, Bortezomib, Velcade

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bortezomib

Arm Type

Experimental

Arm Description

Participants will receive a 1.3 milligram per square meter per dose (mg/m^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Velcade

Intervention Description

Participants will receive a 1.3 milligram per square meter per dose (mg/m^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.

Primary Outcome Measure Information:

Title

Initial Observed Plasma Drug Concentration (Co)

Description

Initial concentration extrapolated to time zero (Co) will be evaluated.

Time Frame