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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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 treatment. Additional objectives of this study are assess the safety and tolerability of bortezomib and follow the levels of paraprotein in patients receiving bortezomib as a way to followup disease burden

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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