Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03910439 · OUTCOME

Number of Participants Overall Best Response

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

What was measured

Response was assessed by the International Myeloma Working Group (IMWG) response criteria, 2016. Minimal Response is ≥25% but ≤49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%; in addition, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required. Stable Disease is not meeting criteria for complete response, very good partial response, partial response, minimal response, or progressive disease. And Progressive Disease is appearance of a new lesion(s), ≥50% increase from nadir in sum of the products of diameters (SPD) of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 cm in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter (μL) if this is the only measure of disease.

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

Minimal Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy1Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy2Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Minimal Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Progressive Disease
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. Minimal Response is ≥25% but ≤49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%; in addition, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required. Stable Disease is not meeting criteria for complete response, very good partial response, partial response, minimal response, or progressive disease. And Progressive Disease is appearance of a new lesion(s), ≥50% increase from nadir in sum of the products of diameters (SPD) of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 cm in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter (μL) if this is the only measure of disease.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 weeks
title
Number of Participants Overall Best Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice