A Phase 2, Two Stage, Open-label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma
The protocol was originally designed as a Simon two stage but after it was determined that
the initial 13 patients enrolled did not meet the definition of a 'responder' according to
the International Uniform Response Criteria for multiple myeloma the protocol was amended to
allow patients who had disease progression at any time or stable disease for 3 cycles and
did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone
added to their dose of ruxolitinib.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma
A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h).
Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Sundar Jagannath, MD
St. Vincent's Comprehensive Cancer Center, New York, New York
United States: Food and Drug Administration
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Albany, New York 12208|