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NCT01484275 · OUTCOME

Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma · Source last updated 2020-01-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 4.7 Years

What was measured

Number of participants who progressed to symptomatic multiple myeloma with stage III of International Staging System (ISS) or abnormal cytogenetic findings were assessed. The ISS system consists of stage I: beta2-microglobulin \< 3.5 milligram per liter (mg/L) and albumin \>= 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/L.

Analysis population: The data was not collected and analyzed for this outcome measure as per the change in planned analysis.

Groups in this outcome

Siltuximab

Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

Placebo

Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Siltuximab0
Placebo0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Number of participants who progressed to symptomatic multiple myeloma with stage III of International Staging System (ISS) or abnormal cytogenetic findings were assessed. The ISS system consists of stage I: beta2-microglobulin \< 3.5 milligram per liter (mg/L) and albumin \>= 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/L.
groups
  1. description
    Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    OG000
    title
    Siltuximab
  2. description
    Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    OG001
    title
    Placebo
population Description
The data was not collected and analyzed for this outcome measure as per the change in planned analysis.
reporting Status
POSTED
time Frame
Up to 4.7 Years
title
Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice