NCT03910439 · OUTCOME

Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline

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: MEAN
Unit: Percent change
Interval / dispersion: Full Range
Time frame: Baseline and up to end of study for individual patient, an average of 11 months

What was measured

Blood samples and bone marrow samples were taken from participants and processed by flow cytometry.

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

Group	Source count
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy	4

Reported measurements

Peripheral blood at baseline

Values in Percent change · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy	0	Not reported	0	0	Not reported

Bone marrow at baseline

Values in Percent change · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy	0	Not reported	0	0	Not reported

Peripheral blood at end of study

Values in Percent change · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy	18	Not reported	-1	1000	Not reported

Bone marrow at end of study

Values in Percent change · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy	55	Not reported	-0.01	1250	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0
value
0
title
Peripheral blood at baseline
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
0
value
0
title
Bone marrow at baseline
categories
measurements
group Id
OG000
lower Limit
-1
upper Limit
1000
value
18
title
Peripheral blood at end of study
categories
measurements
group Id
OG000
lower Limit
-0.01
upper Limit
1250
value
55
title
Bone marrow at end of study

denoms

counts
group Id
OG000
value
4
units
Participants

description

Blood samples and bone marrow samples were taken from participants and processed by flow cytometry.

dispersion Type

Full Range

groups

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

MEAN

reporting Status

POSTED

time Frame

Baseline and up to end of study for individual patient, an average of 11 months

title

Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline

type

SECONDARY

unit Of Measure

Percent change

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

Preserved source evidence · Not medical advice