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

NCT ID: NCT00639002

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib then Ruxolitinib + Dexamethasone

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.

Group Type: EXPERIMENTAL

Ruxolitinib 25 mg

Intervention Type: DRUG

Ruxolitinib was supplied as 5 and 25 mg tablets.

Dexamethasone 40 mg

Intervention Type: DRUG

Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Interventions

Ruxolitinib 25 mg

Ruxolitinib was supplied as 5 and 25 mg tablets.

Intervention Type: DRUG

Dexamethasone 40 mg

Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Intervention Type: DRUG

Other Intervention Names

INCB018424

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sundar Jagannath, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Comprehensive Cancer Center, New York, New York

Locations

Highland, California, United States

Boynton Beach, Florida, United States

New York, New York, United States

Countries

United States

Other Identifiers

INCB 18424-255

Identifier Type: -

Identifier Source: org_study_id