NCT01801436 · REGISTRY CONDITION SEARCH

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2013-05-16

The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Response to Treatment at Day 1 of Cycle 5

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outcome · POSTED

Number of Participants With Response to Treatment at Day 1 of Cycle 7

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outcome · POSTED

Number of Participants With Response to Treatment at Day 11 of Cycle 8

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outcome · POSTED

Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline

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outcome · POSTED

Number of Participants With KPS Score at Day 1 of Cycle 1

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outcome · POSTED

Number of Participants With KPS Score at Day 1 of Cycle 3

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outcome · POSTED

Number of Participants With KPS Score at Day 1 of Cycle 5

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outcome · POSTED

Number of Participants With KPS Score at Day 1 of Cycle 7

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outcome · POSTED

Number of Participants With KPS Score at Day 11 of Cycle 8

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Elimination Half-Life Period (T1/2) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Elimination Half-Life Period (T1/2) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Mean Residence Time (MRT) of Bortezomib in the Body on Day 1 of Cycle 1

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outcome · POSTED

Mean Residence Time (MRT) of Bortezomib in the Body on Day 11 of Cycle 1

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outcome · POSTED

Systemic Clearance (CL) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Systemic Clearance (CL) of Bortezomib on Day 11 of Cycle 1

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outcome · POSTED

Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 1 of Cycle 1

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outcome · POSTED

Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 11 of Cycle 1

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Participants previously diagnosed with multiple myeloma based on standard criteria * Participant has received at least 2 previous lines of therapy for multiple myeloma and, in the Investigator's opinion, currently requires therapy because of relapsed (the return of a medical problem) or progressive disease * Female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from Screening through the Final Visit * If male, the participant agrees to use an acceptable barrier method for contraception from Screening through the Final Visit * Participant has a Karnofsky performance status classifies participants as to their functional impairment and is used to compare effectiveness of different therapies and to assess the prognosis \[outlook, probable outcomes\] in individual participants) greater than 60 Exclusion Criteria: * If the participant received bortezomib in a previous trial, the Participants' best response to bortezomib must be progressive disease * If the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events * Participants who have received nitrosoureas within 6 weeks or any other chemotherapy (treatment of disease, usually cancer, by chemical agents) within 3 weeks before enrollment * Participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment * Human Immunodeficiency Virus (HIV - a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person)-positive or hepatitis-B surface antigen-positive participants or participants with known active hepatitis-C infection
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
intervention Names
Drug: Bortezomib
label
Bortezomib
type
EXPERIMENTAL

interventions

arm Group Labels
Bortezomib
description
Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
name
Bortezomib
other Names
VELCADE
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 14
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.
measure
Number of Participants With Response to Treatment at Day 1 of Cycle 5
time Frame
Day 1 of Cycle 5
description
Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.
measure
Number of Participants With Response to Treatment at Day 1 of Cycle 7
time Frame
Day 1 of Cycle 7
description
Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.
measure
Number of Participants With Response to Treatment at Day 11 of Cycle 8
time Frame
Day 11 of Cycle 8
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline
time Frame
Baseline
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With KPS Score at Day 1 of Cycle 1
time Frame
Day 1 of Cycle 1
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With KPS Score at Day 1 of Cycle 3
time Frame
Day 1 of Cycle 3
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With KPS Score at Day 1 of Cycle 5
time Frame
Day 1 of Cycle 5
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With KPS Score at Day 1 of Cycle 7
time Frame
Day 1 of Cycle 7
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
measure
Number of Participants With KPS Score at Day 11 of Cycle 8
time Frame
Day 11 of Cycle 8
description
The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.
measure
Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1
time Frame
0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1
description
The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.
measure
Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1
time Frame
0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1
description
Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.
measure
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1
time Frame
0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1

Full study description

brief Summary: The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).
detailed Description: This is an open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who have received at least 2 previous lines of therapy (medicine or medical care given to a participant for a disease or condition) and are refractory (not responding to treatment) to or have relapsed (the return of a medical problem) after their last therapy. Eligible participants will receive bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. Blood samples for PK assessment will be collected on specified time points of Day 1, Day 8, and Day 11 of Cycle 1. Efficacy of the participants will primarily be evaluated by recording 'response to treatment' and 'Karnofsky Performance Status'. Participants' safety will be monitored throughout the study.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice