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NCT03634800 · OUTCOME

To Determine Overall Response at 12 Weeks Using International Myeloma Working Group (IMWG) Criteria in Patients Will be Measured

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
12 weeks

What was measured

The primary aim is to estimate the overall response at 12 weeks using IMWG criteria. Per IMWG response criteria, Complete Response (CR) is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR) is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h; Partial Response (PR) is defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h, No change/Stable disease is defined as not meeting criteria for CR, VGPR, PR, or progressive disease; Progressive disease (PD) is defined as an increase of \> 25% from lowest response value; Relapse is define as development of new soft tissue plasmacytomas or Definite increase in the size of existing plasmacytomas or bone lesions.

Analysis population: Out of the 5 patients that started treatment, only 3 patient made it to 12 weeks of treatment.

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/Radiotherapy3

Reported measurements

Source class 1

CR (complete response)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy0Not reportedNot reportedNot reportedNot reported

VGPR (Very Good Partial Response)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy0Not reportedNot reportedNot reportedNot reported

PR (Partial Response)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy0Not reportedNot reportedNot reportedNot reported

No change/Stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy1Not reportedNot reportedNot reportedNot reported

PD (Progressive disease)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy2Not reportedNot reportedNot reportedNot reported

Relapse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab/Radiotherapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      CR (complete response)
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      VGPR (Very Good Partial Response)
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      PR (Partial Response)
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      No change/Stable disease
    5. measurements
      1. group Id
        OG000
        value
        2
      title
      PD (Progressive disease)
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Relapse
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
The primary aim is to estimate the overall response at 12 weeks using IMWG criteria. Per IMWG response criteria, Complete Response (CR) is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR) is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h; Partial Response (PR) is defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h, No change/Stable disease is defined as not meeting criteria for CR, VGPR, PR, or progressive disease; Progressive disease (PD) is defined as an increase of \> 25% from lowest response value; Relapse is define as development of new soft tissue plasmacytomas or Definite increase in the size of existing plasmacytomas or bone lesions.
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
COUNT_OF_PARTICIPANTS
population Description
Out of the 5 patients that started treatment, only 3 patient made it to 12 weeks of treatment.
reporting Status
POSTED
time Frame
12 weeks
title
To Determine Overall Response at 12 Weeks Using International Myeloma Working Group (IMWG) Criteria in Patients Will be Measured
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice