An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)

This study has been completed.

Study NCT00608907 Information provided by Millennium Pharmaceuticals, Inc.

First Received on January 23, 2008. Last Updated on January 26, 2012 History of Changes

Results First Received: March 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Multiple Myeloma Non-Hodgkin's Lymphoma
Interventions:	Drug: bortezomib Drug: bortezomib, rifampicin Drug: bortezomib, dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
VELCADE	Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
VELCADE + Rifampicin	Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
VELCADE + Dexamethasone	Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.

Participant Flow: Overall Study

	VELCADE	VELCADE + Rifampicin	VELCADE + Dexamethasone
STARTED	30	13	18
COMPLETED	18	13	17
NOT COMPLETED	12	0	1
Adverse Event	6	0	1
Death	1	0	0
Withdrawal by Subject	4	0	0
Progressive Disease	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
VELCADE	Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
VELCADE + Rifampicin	Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
VELCADE + Dexamethasone	Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.

Baseline Measures

	VELCADE	VELCADE + Rifampicin	VELCADE + Dexamethasone	Total
Number of Participants [units: participants]	30	13	18	61
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	14	8	8	30
>=65 years	16	5	10	31
Age [units: years] Mean ± Standard Deviation	64.7 ± 10.86	60.2 ± 9.97	62.3 ± 11.72	63.0 ± 10.91
Gender [units: participants]
Female	15	7	9	31
Male	15	6	9	30

Outcome Measures

1. Primary:

Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours [ Time Frame: Cycle 3 day 14 (72 hours post last dose) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Helgi van de Velde, MD, PhD
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: HVDVELDE@ITS.JNJ.COM

No publications provided

Responsible Party:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00608907 History of Changes
Other Study ID Numbers:	26866138-CAN-1006
Study First Received:	January 23, 2008
Results First Received:	March 29, 2011
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration