Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

Inclusion Criteria

Male and female adult patients 18 years or older with a diagnosis of relapsed multiple
myeloma requiring therapy will be eligible for this study.

Key inclusion criteria include:

Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function
tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less then 2
x upper limit of normal [ULN], total bilirubin equal to or less then 1.5 x ULN),
hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to
ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL;
calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum
calcium.

Key exclusion criteria include:

Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy,
active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell
leukemia, or who are transfusion-dependent or received extensive radiation therapy,
systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will
be excluded. Patients taking concurrent medications at entry that may act as inducers or
inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that
drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids
must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of
prednisone or prednisone equivalent at least 2 weeks prior to enrollment.