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A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02268890
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study
Study Start Date : December 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Bortezomib
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.
Drug: Bortezomib
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 Name: Velcade




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268890


Locations
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Taiwan
Changhua, Taiwan
Kaohsiung, Taiwan
Taichung City, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd

Additional Information:
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Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT02268890     History of Changes
Other Study ID Numbers: CR104583
26866138MMY4073 ( Other Identifier: Johnson & Johnson Taiwan Ltd. )
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Johnson & Johnson Taiwan Ltd:
Multiple Myeloma
Bortezomib
Velcade

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents