Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00470093
• Other study ID #: J0620
• Secondary ID: P30CA006973P01CA
• Status: Terminated
• Phase: Early Phase 1
• Start date: October 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• recombinant interferon-a

• recombinant interleukin-6

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.	Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.	Up to 5 months
Primary	Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events	Number of participants who discontinued the protocol due to adverse events.	Up to 5 months
Primary	Optimal Dose of Interleukin-6	Maximum tolerated dose found using a standard 3+3 dose escalation model.	Up to 5 months
Primary	Impact of Treatment on Growth of Myeloma Cells	Percentage change in growth of in vitro myeloma cells from baseline to end of study.	Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study