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Completed

NCT Number: NCT00639002

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Highland, California, United States

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About this study

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who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ruxolitinib 25 mg

Drug

Ruxolitinib was supplied as 5 and 25 mg tablets.

Other names: INCB018424

Dexamethasone 40 mg

Drug

Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

    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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2008
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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