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A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion of subject until disease progression

Safety Issue:


Principal Investigator

Lynne Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

May 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of ChicagoChicago, Illinois  60637
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
UCLA Oncology-Hematology Associates, Ltd.Los Angeles, California  90095