Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

Inclusion criteria

• Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
• Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)
• Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.
• Presence of measurable disease as defined by at least one of the following;

• Serum M-protein ≥ 1g/dL (measurable disease)
• Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)

Exclusion criteria

• Patients with non-secretory, or oligosecretory, multiple myeloma.
• Patients with symptomatic amyloidosis, or with plasma cell leukemia.
• Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.

Other protocol-defined inclusion/exclusion criteria may apply