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

Incyte

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Ruxolitinib 25 mg; Drug: Dexamethasone 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639002

INCB 18424-255

Details and patient eligibility

About

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.

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Ruxolitinib then Ruxolitinib + Dexamethasone

Experimental group

Description:

Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.

Treatment:

Drug: Dexamethasone 40 mg

Drug: Ruxolitinib 25 mg