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

NCT00470093 | Terminated Early Phase 1 Results

• 4 other identifiers: J0620P30CA006973P01CA015396NA_00002178
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Optimal Dose of Interleukin-6

  Maximum tolerated dose found using a standard 3+3 dose escalation model.

  Up to 5 months

• 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

Study Arms (1)

Interleukin-6 and Interferon-α

EXPERIMENTAL

Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.

Biological: recombinant interferon-α; Biological: recombinant interleukin-6

Interventions

recombinant interferon-α BIOLOGICAL

Interleukin-6 and Interferon-α

recombinant interleukin-6 BIOLOGICAL

Interleukin-6 and Interferon-α

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Interleukin-6

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Carol Ann Huff
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

huffca@jhmi.edu

410-955-8842

Study Officials

• Carol A Huff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 16, 2018
• Results First Posted: November 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)