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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Multiple Myeloma

Thank you

Trial Information

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 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did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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).

Outcome Time Frame:

Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).

Safety Issue:

No

Principal Investigator

Sundar Jagannath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Vincent's Comprehensive Cancer Center, New York, New York

Authority:

United States: Food and Drug Administration

Study ID:

INCB 18424-255

NCT ID:

NCT00639002

Start Date:

March 2008

Completion Date:

July 2010

Related Keywords:

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208