The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed 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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Ruxolitinib was supplied as 5 and 25 mg tablets.
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
Unnamed facility
Highland, California, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
New York, New York, United States
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).
Time frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma
Progressive Disease requires 1 or more of the following: Increase of ≥ 25% from baseline in: Serum M-component and/or (increase ≥ 0.5 g/dL). Urine M-component and/or (increase ≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be \> l0 mg/dL. Bone marrow plasma cell percentage ≥ 10%. Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
Time frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
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