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

Last updated: January 15, 2018
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

2

Condition

Bone Neoplasm

Multiple Myeloma

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00639002
INCB 18424-255
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

  • Intracranial disease or epidural disease.

Study Design

Total Participants: 13
Study Start date:
March 01, 2008
Estimated Completion Date:
July 31, 2010

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Connect with a study center

  • Highland, California 92346
    United States

    Site Not Available

  • Boynton Beach, Florida 33435
    United States

    Site Not Available

  • New York, New York 10011
    United States

    Site Not Available

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