Multiple Myeloma
Conditions
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 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and FGFR that may be involved in multiple myeloma.
Interventions
DRUGXL999
Treatment consisted of 8 weekly infusions of 2.4 mg/kg of XL999 with each infusion given over 4 hours, unless drug-related toxicity required a dosing delay or adjustment. In the absence of progressive disease and unacceptable toxicity, subjects may have received XL999 treatment weekly for up to 1 year on this study.
Sponsors
Symphony Evolution, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Inclusion of subject until disease progression |
| Safety and tolerability | Inclusion until 30 days post last treatment |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | Inclusion until disease progression |
| Progression-free survival | Inclusion until disease progression |
| Overall survival | Inclusion until 180-day Follow-up or death |
Countries
United States
Outcome results
None listed