The purpose of this study is to determine clinical efficacy and safety of INCB018424, a small molecule Janus kinase (JAK) inhibitor, in patients with refractory or relapsed 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.

Conditions

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Multiple Myeloma

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Single Group Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

  • Safety and tolerability of patients and response rates will be assessed using International Uniform Response Criteria (IRC) for multiple myeloma for all patients treated with study medication.
    [Time Frame: End Of Study]
    [Designated as safety issue: No]

Secondary Outcome Measures:

  • To study preliminary effectiveness of oral INCB018424 alone or in combination with dexamethasone in a patient population diagnosed with multiple myeloma.
    [Time Frame: End of study]
    [Designated as safety issue: No]

Study Start

March 2008 -September 2008

Eligibility & Criteria

  • Ages Eligible for Study: 

     

       18 Years and older

  •  

        Genders Eligible for Study:

     

       Both  

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.

Total Enrolment

37

Contact Details

Sara Malhotra (PhD)
Phone No: + 302-498-6830
Email: smalhotra@incyte.com

Location:

 

 Highland, California
USA, 9234