Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor in Patients with Multiple Myeloma

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