The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).
To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT). To assess the time to progression and disease free survival of patients treated with PTK787/ZK 222584. To assess the safety and tolerability of PTK787/ZK 222584 in multiple myeloma patients following ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Washington University School of Medicine
St Louis, Missouri, United States
Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug
Time frame: Day 90
Time to Progression
Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met. * 25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation. * 25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation. * 35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. * Increase in the size of existing bone lesions or soft tissue plasmacytomas * New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression). * Hypercalcemia - corrected serum calcium \> 11.5 mg/dL
Time frame: Until the patient progresses or expires (up to 457 days)
Safety and Tolerability of PTK787/ZK 222584
Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.
Time frame: 30 days after treatment ends [median of 15 cycles (11-32)]
Disease Free Survival
Time frame: Until the patient expires
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