Multiple MyelomaPhase 2NCT00639002
A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma
A Phase 2 study testing Ruxolitinib 25 mg and Dexamethasone 40 mg in people with Multiple Myeloma, run by Incyte Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ruxolitinib 25 mg and Dexamethasone 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Received anti-cancer medications or investigational therapy in the past 28 days.
- Intracranial disease or epidural disease.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boynton Beach, Florida, 33435
Study site
Highland, California, 92346
Study site
New York, New York, 10011
About this study
Official title: A Phase 2, Two Stage, Open-label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Ruxolitinib 25 mg, Dexamethasone 40 mg
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 25 mgDrug
Also called INCB018424
Ruxolitinib was supplied as 5 and 25 mg tablets.
Dexamethasone 40 mgDrug
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ruxolitinib 25 mg; Drug: Dexamethasone 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sundar Jagannath, MD, Principal investigator, St. Vincent's Comprehensive Cancer Center, New York, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639002
- Sponsor's protocol ID
- INCB 18424-255
- Status last verified
- Jan 2018
- First submitted
- 12 Mar 2008
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two Stage, Open-label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00639002
- Acronym / sponsor ID
- INCB 18424-255
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 23 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib then Ruxolitinib + Dexamethasone | Experimental | Drug: Ruxolitinib 25 mg, Drug: Dexamethasone 40 mgPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Received anti-cancer medications or investigational therapy in the past 28 days.
- Intracranial disease or epidural disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 25 mgAlso: INCB018424Ruxolitinib was supplied as 5 and 25 mg tablets. | Drug | Ruxolitinib then Ruxolitinib + Dexamethasone |
| Dexamethasone 40 mgDexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg. | Drug | Ruxolitinib then Ruxolitinib + Dexamethasone |
Primary outcome
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).
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).
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Jagannath, MD principal investigator
St. Vincent's Comprehensive Cancer Center, New York, New York
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib 25 mg and Dexamethasone 40 mg in people with Multiple Myeloma, run by Incyte Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.