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A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a


N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a


OBJECTIVES:

- Determine the response rate in patients with recurrent multiple myeloma treated with
recombinant interferon alfa and recombinant interleukin-6.

- Determine the safety and optimal dose of this regimen in these patients.

- Determine the toxicity of this regimen in these patients.

- Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in
vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1
month later, patients also receive recombinant interleukin-6 SC once daily. Treatment
continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of recurrent multiple myeloma

- Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

- Performance status 0-3

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Carol A. Huff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

J0620 CDR0000543428

NCT ID:

NCT00470093

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410