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

A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation

This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma

Inclusion Criteria:

1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.

2. 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)

3. 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.

4. 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:

1. Patients with non-secretory, or oligosecretory, multiple myeloma.
2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
3. 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