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



Status:Completed
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/15/2018
Start Date:March 2008
End Date:July 2010

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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.

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not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added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.

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.
We found this trial at
3
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New York, NY
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Boynton Beach, FL
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Highland, CA
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