NCT03951220 · OUTCOME

Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs % Change in ADC (Apparent Diffusion Coefficient)]

The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss · Source last updated 2025-08-19

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

Measure: MEAN
Unit: ADC Ratio (follow-up / baseline)
Interval / dispersion: Standard Deviation
Time frame: Comparison between baseline and follow-up at 6 month

What was measured

Secondary Objective 1: To assess whether the novel Magnetic Resonance (MR) protocol can improve detection of longitudinal changes in tumour burden in patients with new or relapsed myeloma during therapy, compared to the International Myeloma Working Group (IMWG) Response Group classification alone. This section compared two indicators of therapy response: 1. % change in Apparent Diffusion Coefficient (ADC) measurements in participants where there was a lytic bone lesion identified on both baseline and follow-up novel MR scan amenable to ADC measurement \[1\]. 2. MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) based on expert radiologist interpretation of paired novel MR imaging, guided by Messiou et. al. criteria \[1\]. Ref: \[1\] Messiou, Christina, et al. "Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS)." Radiology 291.1 (2019): 5-13

Analysis population: Participants with new or relapsed myeloma who had successfully measured paired novel MR scans at baseline and 6-month follow-up, with a successfully graded MY-RADS RAC, and a lytic bone lesion also a lytic bone lesion amenable to longitudinal calculation of % change in ADC.

Groups in this outcome

Group 1a: New Myeloma

Patients from Group 1a who had MY-RADS RAC score

Group 1b: Relapsed Myeloma

Patients from Group 1b who had MY-RADS RAC score

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
Group 1a: New Myeloma	5
Group 1b: Relapsed Myeloma	2

Reported measurements

MY-RADS RAC 1: Highly likely to be responding

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	1
Group 1b: Relapsed Myeloma	1

Values in ADC Ratio (follow-up / baseline) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Group 1a: New Myeloma	0.45	NA	Not reported	Not reported	1 data point, not amenable to standard deviation calculation
Group 1b: Relapsed Myeloma	1.40	NA	Not reported	Not reported	1 data point, not amenable to standard deviation calculation

MY-RADS RAC 2: Likely to be responding

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	2
Group 1b: Relapsed Myeloma	1

Values in ADC Ratio (follow-up / baseline) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Group 1a: New Myeloma	1.29	0.45	Not reported	Not reported	Not reported
Group 1b: Relapsed Myeloma	0.57	NA	Not reported	Not reported	1 data point, not amenable to standard deviation calculation

MY-RADS RAC 3: Stable

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	2
Group 1b: Relapsed Myeloma	0

Values in ADC Ratio (follow-up / baseline) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Group 1a: New Myeloma	1.61	0.45	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
1 data point, not amenable to standard deviation calculation
group Id
OG000
spread
NA
value
0.45
comment
1 data point, not amenable to standard deviation calculation
group Id
OG001
spread
NA
value
1.40
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
units
Participants
title
MY-RADS RAC 1: Highly likely to be responding
categories
measurements
group Id
OG000
spread
0.45
value
1.29
comment
1 data point, not amenable to standard deviation calculation
group Id
OG001
spread
NA
value
0.57
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
1
units
Participants
title
MY-RADS RAC 2: Likely to be responding
categories
measurements
group Id
OG000
spread
0.45
value
1.61
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
units
Participants
title
MY-RADS RAC 3: Stable

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
2
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Patients from Group 1a who had MY-RADS RAC score
id
OG000
title
Group 1a: New Myeloma
description
Patients from Group 1b who had MY-RADS RAC score
id
OG001
title
Group 1b: Relapsed Myeloma

param Type

MEAN

population Description

Participants with new or relapsed myeloma who had successfully measured paired novel MR scans at baseline and 6-month follow-up, with a successfully graded MY-RADS RAC, and a lytic bone lesion also a lytic bone lesion amenable to longitudinal calculation of % change in ADC.

reporting Status

POSTED

time Frame

Comparison between baseline and follow-up at 6 month

title

Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [MY-RADS RAC (Myeloma Response Assessment and Diagnosis System Response Assessment Classification) vs % Change in ADC (Apparent Diffusion Coefficient)]

type

SECONDARY

unit Of Measure

ADC Ratio (follow-up / baseline)

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Preserved source evidence · Not medical advice