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NCT Number: NCT02268890

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhua, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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.

Other names: Velcade

Primary outcomes

  1. Initial Observed Plasma Drug Concentration (Co)

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

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

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

    Maximum observed plasma concentration (Cmax) will be observed.

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

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

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

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

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

    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.

  5. Terminal Half-life (t1/2)

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

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

  6. Terminal rate constant (lamda[z])

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

    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.

  7. Systemic clearance (CL)

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

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

  8. Apparent Volume of Distribution (Vd)

    Time frame: 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14

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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Taiwan Ltd

Industry

Registry information

Official study title

Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2014
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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