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NCT03910439 · OUTCOME

Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment

Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma · Source last updated 2021-05-12

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

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
up to end of study for individual patient, an average of 11 months

What was measured

Response was assessed by the International Myeloma Working Group (IMWG) response criteria, 2016. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry.

Groups in this outcome

1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy

Avelumab 800 mg IV every two weeks in combination with radiation therapy Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy

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

Analysis denominator · Participants

GroupSource count
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy4

Reported measurements

Source class 1
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy0Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Response was assessed by the International Myeloma Working Group (IMWG) response criteria, 2016. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry.
dispersion Type
95% Confidence Interval
groups
  1. description
    Avelumab 800 mg IV every two weeks in combination with radiation therapy Avelumab: Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle External beam radiotherapy: 5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy
    id
    OG000
    title
    1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy
param Type
NUMBER
reporting Status
POSTED
time Frame
up to end of study for individual patient, an average of 11 months
title
Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment
type
SECONDARY
unit Of Measure
Proportion of participants

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

Preserved source evidence · Not medical advice