NCT00639002

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ruxolitinib 25 mg	Ruxolitinib was supplied as 5 and 25 mg tablets.
DRUG	Dexamethasone 40 mg	Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-03-19
• Last updated: 2018-02-13
• Results posted: 2012-01-23

Locations

3 sites across 1 country: United States