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not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added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not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added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