NCT00639002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2012

Completed
Last Updated

February 13, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

March 12, 2008

Results QC Date

December 16, 2011

Last Update Submit

January 15, 2018

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma

    A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to \< 200 mg per 24 h).

    Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).

Secondary Outcomes (1)

  • Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma

    Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).

Study Arms (1)

Ruxolitinib then Ruxolitinib + Dexamethasone

EXPERIMENTAL

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.

Drug: Ruxolitinib 25 mgDrug: Dexamethasone 40 mg

Interventions

Ruxolitinib 25 mgDRUG

Ruxolitinib was supplied as 5 and 25 mg tablets.

Also known as: INCB018424
Ruxolitinib then Ruxolitinib + Dexamethasone
Dexamethasone 40 mgDRUG

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

Ruxolitinib then Ruxolitinib + Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Received anti-cancer medications or investigational therapy in the past 28 days.
  • Intracranial disease or epidural disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Highland, California, 92346, United States

Location

Unknown Facility

Boynton Beach, Florida, 33435, United States

Location

Unknown Facility

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ruxolitinibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Study Director
Organization
Incyte Corporation
855 463-3463

Study Officials

  • Sundar Jagannath, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 13, 2018

Results First Posted

January 23, 2012

Record last verified: 2018-01

Locations

US(3)