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| 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
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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. |
| 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
| 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. |
| 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
| 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). ] |
| 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). ] |
More Information
| 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:
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| 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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| 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 |