Conditions: Multiple Myeloma
Keywords: Myeloma PTK
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: PTK787/ZK 222584
Intervention descriptions: intervention 1: None

Protocol document: