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

Part of paid clinical trials in Highland, California.

Sponsor
Incyte Corporation
Study ID
NCT00639002
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib 25 mg — DRUG
    Ruxolitinib was supplied as 5 and 25 mg tablets.
  • Dexamethasone 40 mg — DRUG
    Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Study Details

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.

Key Dates

Start date
Mar 31, 2008
Status verified
Jan 2018
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma [ Time Frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months). ]

Locations (3)

FacilityCityStateZIPSite coordinators
-HighlandCalifornia92346-
-Boynton BeachFlorida33435-
-New YorkNew York10011-

Find similar trials in Highland, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer

Related Studies