Study of XL999 in Patients With Multiple Myeloma

Inclusion Criteria:

Males and females with a diagnosis of MM based on bone marrow aspirate and biopsy with ≥10% plasma cells (or biopsy of a tissue with monoclonal plasma cells), M protein level in the serum or urine, and evidence of end organ or tissue impairment (hypercalcemia, renal insufficiency, anemia, or lytic bone lesions), as defined by The International Myeloma Working Group Criteria (2003), at initial diagnosis (before initiation of chemotherapy)
Measurable disease defined as serum and/or urine M component by electrophoresis
Refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
Concurrent therapy with a bisphosphonate is acceptable
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Adequate liver function
No other malignancies within 5 years
Signed informed consent

Exclusion Criteria:

Nonsecretory myeloma, monoclonal gammopathy of uncertain significance (MGUS), or smoldering myeloma
Anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of XL999 treatment
Hematopoietic stem cell transplantation within the previous 6 weeks
Radiation to ≥33% of bone marrow within 30 days of XL999 treatment
Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs that were administered >30 prior to study enrollment
Uncontrolled and/or intercurrent illness
Pregnant or breastfeeding females
Known HIV