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

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

Official Title
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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

Conditions
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Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: TKI258


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKI258<br> | Drug: TKI258<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and severity of adverse events as per CTCAE |  | throughout the study | 
| Progression free survival (PFS) |  | every 4 weeks | 
| Plasma exposure of TKI258 |  | during the first 3 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory, Multiple myeloma, relapsed, t(4;14), FGFR3