Back to resultsA Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib 25 mg
Dexamethasone 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ruxolitinib then Ruxolitinib + Dexamethasone
Arm 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00639002
Brief Title
A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib then Ruxolitinib + Dexamethasone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 25 mg
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib was supplied as 5 and 25 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 40 mg
Intervention Description
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
Primary Outcome Measure Information:
Title
Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma
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).
Time Frame
Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Secondary Outcome Measure Information:
Title
Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma
Description
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundar Jagannath, MD
Organizational Affiliation
St. Vincent's Comprehensive Cancer Center, New York, New York
Official's Role
Principal Investigator
Facility Information:
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
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