NCT02268890

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 multiple-myeloma

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4 multiple-myeloma

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

October 15, 2014

Last Update Submit

July 8, 2016

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaBortezomibVelcade

Outcome Measures

Primary Outcomes (8)

  • Initial Observed Plasma Drug Concentration (Co)

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

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

  • Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration (Cmax) will be observed.

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

  • 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.

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

  • 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.

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

  • Terminal Half-life (t1/2)

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

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

  • 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.

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

  • Systemic clearance (CL)

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

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

  • 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).

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

Study Arms (1)

Bortezomib

EXPERIMENTAL

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

Interventions

BortezomibDRUG

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.

Also known as: Velcade
Bortezomib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Changhua, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 20, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

TW(6)