Status:
TERMINATED
Study of XL999 in Patients With Multiple Myeloma
Lead Sponsor:
Symphony Evolution, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with relapsed or refractory multiple myeloma. XL999 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00304590
Start Date
February 1 2006
End Date
May 1 2007
Last Update
February 22 2010
Active Locations (3)
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1
UCLA Oncology-Hematology Associates, Ltd.
Los Angeles, California, United States, 90095
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435