Status:
COMPLETED
Expanded Access Protocol (EAP) to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their last treatmen...
Detailed Description
Multiple myeloma is uniformly fatal. Responses achieved after multiple lines of therapy are normally of short duration. Therefore, all patients with multiple myeloma will eventually relapse, having be...
Eligibility Criteria
Inclusion
- Patients with previous diagnosis of multiple myeloma based on standard criteria
- patient has received at least 2 previous lines of therapy for multiple myeloma and, currently requires therapy because of relapsed or progressive disease
- If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit
- If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit
- patient has a Karnofsky performance status \>= 60
- patient meets defined pretreatment laboratory criteria
Exclusion
- If patient received bortezomib in a previous clinical trial, the patient's best response to bortezomib was progressive disease
- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment, corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before enrollment
- Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI CTC
- Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Patient has cardiac amyloidosis
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT00440635
Start Date
January 1 2004
End Date
October 1 2006
Last Update
April 16 2013
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