A Phase 2 interventional study of Ruxolitinib 25 mg and Dexamethasone 40 mg in Multiple Myeloma, sponsored by Incyte Corporation. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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.
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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
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Exclusion Criteria:
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 mg · Drug: Dexamethasone 40 mg
Ruxolitinib was supplied as 5 and 25 mg tablets.
Also known as: INCB018424
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
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).
Time frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma
Progressive Disease requires 1 or more of the following: Increase of ≥ 25% from baseline in: Serum M-component and/or (increase ≥ 0.5 g/dL). Urine M-component and/or (increase ≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be \> l0 mg/dL. Bone marrow plasma cell percentage ≥ 10%. Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
Time frame: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
| Milestone | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| Started | 13 |
| Received ruxolitinib | 13 |
| Received ruxolitinib + dexamethasone | 7 |
| Completed | 0 |
| Not completed | 13 |
| Withdrew: Death | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Disease progression | 3 |
| Withdrew: Physician decision | 6 |
| Withdrew: Lack of efficacy | 1 |
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).
| participants | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma | 0 |
Progressive Disease requires 1 or more of the following: Increase of ≥ 25% from baseline in: Serum M-component and/or (increase ≥ 0.5 g/dL). Urine M-component and/or (increase ≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be \> l0 mg/dL. Bone marrow plasma cell percentage ≥ 10%. Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
No measurements were reported for this outcome.
Collected over Baseline to end of study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ruxolitinib | — | 6/13 (46.2%) | 11/13 (84.6%) |
| Ruxolitinib + Dexamethasone | — | 6/7 (85.7%) | 6/7 (85.7%) |
| Event | Ruxolitinib | Ruxolitinib + Dexamethasone |
|---|---|---|
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/13 | 2/7 |
| PneumoniaInfections and infestations | 1/13 | 2/7 |
| Pericardial effusionCardiac disorders | 0/13 | 1/7 |
| Disease progressionGeneral disorders | 1/13 | 1/7 |
| FatigueGeneral disorders | 0/13 | 1/7 |
| PainGeneral disorders | 0/13 | 1/7 |
| Pneumococcal sepsisInfections and infestations | 0/13 | 1/7 |
| OverdoseInjury, poisoning and procedural complications | 0/13 | 1/7 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/13 | 1/7 |
| Lung carcinoma cell type unspecified stage IVNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/13 | 1/7 |
| Event | Ruxolitinib | Ruxolitinib + Dexamethasone |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 3/13 | 3/7 |
| HypokalaemiaMetabolism and nutrition disorders | 1/13 | 3/7 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/13 | 3/7 |
| AnaemiaBlood and lymphatic system disorders | 4/13 | 2/7 |
| NeutropeniaBlood and lymphatic system disorders | 4/13 | 2/7 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/13 | 2/7 |
| FatigueGeneral disorders | 4/13 | 2/7 |
| Blood creatinine increasedInvestigations | 4/13 | 2/7 |
| LeukopeniaBlood and lymphatic system disorders | 2/13 | 2/7 |
| TachycardiaCardiac disorders | 0/13 | 2/7 |
| Age, Continuous(years) | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| Mean | 74.7 ± 8.36 |
| Sex: Female, Male(Participants) | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| Female | 5 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| 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(participants) | Ruxolitinib Then Ruxolitinib + Dexamethasone |
|---|---|
| I | 0 |
| II | 4 |
| III | 4 |
| Unknown | 5 |
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