NCT00639002 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-02-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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. Exclusion Criteria: * Received anti-cancer medications or investigational therapy in the past 28 days. * Intracranial disease or epidural disease.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: Ruxolitinib 25 mg
Drug: Dexamethasone 40 mg
label
Ruxolitinib then Ruxolitinib + Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Ruxolitinib then Ruxolitinib + Dexamethasone
description
Ruxolitinib was supplied as 5 and 25 mg tablets.
name
Ruxolitinib 25 mg
other Names
INCB018424
type
DRUG
arm Group Labels
Ruxolitinib then Ruxolitinib + Dexamethasone
description
Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
name
Dexamethasone 40 mg
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 13
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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).
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).

secondary Outcomes

description
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.
measure
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).

Full study description

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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice