PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of PTK787/ZK 222584, a Novel, Oral Angiogenesis Inhibitor as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma Following High Dose Chemotherapy and Autologous Stem Cell Transplant|
- 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 ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: Until the patient progresses or expires (up to 457 days) ] [ Designated as safety issue: No ]
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
- Safety and Tolerability of PTK787/ZK 222584 [ Time Frame: 30 days after treatment ends [median of 15 cycles (11-32)] ] [ Designated as safety issue: Yes ]Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.
- Disease Free Survival [ Time Frame: Until the patient expires ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: PTK787/ZK 222584
Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
Drug: PTK787/ZK 222584
Other Name: N/Bemzoylstaurosporine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240162
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ravi Vij, M.D.||Washington University School of Medicine|