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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639002
• Other study ID #: INCB 18424-255
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: January 15, 2018
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2018
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma with evidence of measurable disease.

• Relapsed or refractory disease with at least one line of prior therapy.

• Adequate bone marrow reserve.

Exclusion Criteria:

• Received anti-cancer medications or investigational therapy in the past 28 days.

• Intracranial disease or epidural disease.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Ruxolitinib 25 mg
Ruxolitinib was supplied as 5 and 25 mg tablets.
• Dexamethasone 40 mg
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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.	Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).