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
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
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
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 become refractory to therapy and subsequently will die of their cancer. The
 rationale of this study is that bortezomib as a novel agent may allow additional periods of
 response due to its different mechanisms of action. This is an open-label, single-arm,
 multicenter, non-comparative study to provide expanded access to bortezomib to patients with
 multiple myeloma that have received at least two previous lines of therapy and are refractory
 to or have relapsed after their last treatment. Patients will receive treatment with
 bortezomib 1.3 mg/m2 on day 1, 4, 8 and 11 of a 3-week cycle. No treatment will be
 administered on the last 10 days of each cycle. Treatment may be repeated for up to 8 cycles
 with possible extension if patient is still responding at the end of the 8 cycle period.
 Bortezomib 1.3 mg/m2 will be administered as an IV bolus
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