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

January 15, 2018 updated by: Incyte Corporation

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

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.

Study Overview

Status

Completed

Conditions

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Highland, California, United States, 92346
    • Florida
      • Boynton Beach, Florida, United States, 33435
    • New York
      • New York, New York, United States, 10011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib then Ruxolitinib + Dexamethasone
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.
Ruxolitinib was supplied as 5 and 25 mg tablets.
Other Names:
  • INCB018424
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma
Time Frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma
Time Frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sundar Jagannath, MD, St. Vincent's Comprehensive Cancer Center, New York, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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