Status:
COMPLETED
A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 b...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01801436
Start Date
December 1 2006
End Date
April 1 2008
Last Update
May 16 2013
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