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NCT03634800 · OUTCOME

To Determine the Median Overall Survival for Patients Treated With Immunotherapy and Radiotherapy Will be Assessed.

Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M) · Source last updated 2021-08-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
through study completion

What was measured

Median overall survival for patients treated with immunotherapy and radiotherapy will be assessed. overall survival will be defined as the time from first treatment day until death. Overall survival will be assessed by Kaplan-Meier survival analysis and 95% confidence interval.

Analysis population: All patients withdrew consent after progressing, so no follow up survival data was collected (with the exception of 1 patient who only allowed for survival follow up after being taken off study for progression).

Groups in this outcome

Nivolumab/Radiotherapy

All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion. * Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached * Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached. Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.

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

Analysis denominator · Participants

GroupSource count
Nivolumab/Radiotherapy1

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy17.96Not reported17.9617.96Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.96
        upper Limit
        17.96
        value
        17.96
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Median overall survival for patients treated with immunotherapy and radiotherapy will be assessed. overall survival will be defined as the time from first treatment day until death. Overall survival will be assessed by Kaplan-Meier survival analysis and 95% confidence interval.
dispersion Type
95% Confidence Interval
groups
  1. description
    All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion. * Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached * Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached. Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.
    id
    OG000
    title
    Nivolumab/Radiotherapy
param Type
MEDIAN
population Description
All patients withdrew consent after progressing, so no follow up survival data was collected (with the exception of 1 patient who only allowed for survival follow up after being taken off study for progression).
reporting Status
POSTED
time Frame
through study completion
title
To Determine the Median Overall Survival for Patients Treated With Immunotherapy and Radiotherapy Will be Assessed.
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice