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NCT00470093 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
EARLY PHASE1
Status at capture
TERMINATED
Registry last update
2018-11-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.

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outcome · POSTED

Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events

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outcome · POSTED

Optimal Dose of Interleukin-6

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outcome · POSTED

Impact of Treatment on Growth of Myeloma Cells

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: recombinant interferon-α
    2. Biological: recombinant interleukin-6
    label
    Interleukin-6 and Interferon-α
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Interleukin-6 and Interferon-α
    name
    recombinant interferon-α
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Interleukin-6 and Interferon-α
    name
    recombinant interleukin-6
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
    time Frame
    Up to 5 months
  2. description
    Number of participants who discontinued the protocol due to adverse events.
    measure
    Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
    time Frame
    Up to 5 months
  3. description
    Maximum tolerated dose found using a standard 3+3 dose escalation model.
    measure
    Optimal Dose of Interleukin-6
    time Frame
    Up to 5 months
  4. description
    Percentage change in growth of in vitro myeloma cells from baseline to end of study.
    measure
    Impact of Treatment on Growth of Myeloma Cells
    time Frame
    Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
Full study description
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.
detailed 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e90ecbeda96a7c6a23d3
      requested nct id
      NCT00470093
      primary nct id
      NCT00470093
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      07924af0d972413d8f9dec79158c93bc9a4b75109d9e2bc5d18b22e0e3e9addb
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e90ecbeda96a7c6a23d3
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00470093
      occurrences
      1. context exact
        NCT00470093
        end
        11
        exact text
        NCT00470093
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/968/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      5882ef4be063c08695451a136f573639c7b32392a646d81b90fbcc4a0199cff8

    Preserved source evidence · Not medical advice