Multiple Myeloma Clinical Trial
Official title:
A Randomized, Triple-arm, Controlled, Open-label, Multicenter Phase II Study Assessing Two Different Doses of Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma
The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at
two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2
i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in
patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will
be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due
to disease progression or unacceptable toxicity or for other reasons.
Patients who discontinue the study treatment for reasons other than documented disease
progression will be followed for disease assessments every 8 weeks until progression. All
patients will be followed for survival until 3 years have passed from their entry into the
study, or they have discontinued the follow up earlier.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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