A Post Approval Commitment Study for Pharmacokinetic Analysis and Providing Expanded Access to Bortezomib (Velcade) for Patients With Multiple Myeloma Who Have Received at Least Two Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma in Taiwan
18 Years
65 Years
Both
Multiple Myeloma
Trial Information
A Post Approval Commitment Study for Pharmacokinetic Analysis and Providing Expanded Access to Bortezomib (Velcade) for Patients With Multiple Myeloma Who Have Received at Least Two Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma in Taiwan
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Response to Treatment at Day 1 of Cycle 5
Outcome 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.
Outcome Time Frame:
Day 1 of Cycle 5
Safety Issue:
No
Principal Investigator
Johnson & Johnson Taiwan Ltd Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Taiwan Ltd
Authority:
Taiwan: Institutional Review Board
Study ID:
CR013843
NCT ID:
NCT01801436
Start Date:
December 2006
Completion Date:
April 2008
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Bortezomib
- Velcade
- Multiple Myeloma
- Neoplasms, Plasma Cell
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