A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma

Arms (1)

1. type

   EXPERIMENTAL

   label

   Ruxolitinib then Ruxolitinib + Dexamethasone

   description

   Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.

   interventionNames

   1. Drug: Ruxolitinib 25 mg
   2. Drug: Dexamethasone 40 mg

Primary outcomes (1)

1. measure

   Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma

   timeFrame

   Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).

   description

   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).