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NCT03634800 · OUTCOME

To Determine the Median Progression Free Survival (PFS) Will be Assessed in Patients Treated With Immunotherapy and Radiotherapy.

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
days
Interval / dispersion
95% Confidence Interval
Time frame
through study completion

What was measured

Median progression free survival for patients treated with immunotherapy and radiotherapy will be assessed. Progression free survival (PFS) will be defined as the time from first treatment day until objective or symptomatic progression. PFS will be defined as the time from first treatment day until objective or symptomatic progression and PFS will be assessed by Kaplan-Meier survival analysis and 95% confidence interval.

Analysis population: 4 patient progressed while on study.

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/Radiotherapy4

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy33.75Not reported2156Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21
        upper Limit
        56
        value
        33.75
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Median progression free survival for patients treated with immunotherapy and radiotherapy will be assessed. Progression free survival (PFS) will be defined as the time from first treatment day until objective or symptomatic progression. PFS will be defined as the time from first treatment day until objective or symptomatic progression and PFS 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
4 patient progressed while on study.
reporting Status
POSTED
time Frame
through study completion
title
To Determine the Median Progression Free Survival (PFS) Will be Assessed in Patients Treated With Immunotherapy and Radiotherapy.
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice