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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Relapsed Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma
Interventions:	Drug: Ruxolitinib 25 mg Drug: Dexamethasone 40 mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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 for 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.

Description

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 for 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.

Participant Flow: Overall Study

	Ruxolitinib Then Ruxolitinib + Dexamethasone
STARTED	13
Received Ruxolitinib	13
Received Ruxolitinib + Dexamethasone	7
COMPLETED	0
NOT COMPLETED	13
Death	1
Adverse Event	1
Protocol Violation	1
Disease progression	3
Physician Decision	6
Lack of Efficacy	1

Baseline Characteristics

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Reporting Groups

	Description
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 for 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.

Description

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 for 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.

Baseline Measures

	Ruxolitinib Then Ruxolitinib + Dexamethasone
Number of Participants [units: participants]	13
Age [units: years] Mean ± Standard Deviation	74.7 ± 8.36
Gender [units: participants]
Female	5
Male	8
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	10
More than one race	0
Unknown or Not Reported	0
Stage of multiple myeloma at initial diagnosis [units: participants]
I	0
II	4
III	4
Unknown	5

Outcome Measures

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1. Primary:

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). ]

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2. Secondary:

Time to Disease Progression 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). ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Incyte Corporation
phone: 855 463-3463

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00639002 History of Changes
Other Study ID Numbers:	INCB 18424-255
Study First Received:	March 12, 2008
Results First Received:	December 16, 2011
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration