NCT03951220 · OUTCOME

Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [% Change in ADC (Apparent Diffusion Coefficient) vs IMWG (International Myeloma Working Group) Response Group Classification]

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 6month

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. IMWG Response Group classification \[1\], based on % change in serum paraprotein 2. % 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 \[2\]. Ref: 1. https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple 2. 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 who had successfully measured paired serum paraprotein (amenable to IMWG Response Group classification) and novel MR scans (with a lytic bone lesion amenable to ADC measurement, with a successfully calculated % change in ADC) at baseline and 6-month follow-up.

Groups in this outcome

Group 1a: New Myeloma

Patients with new myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.

Group 1b: Relapsed Myeloma

Patients with relapsed myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.

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

IMWG: Progressive

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	1
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	1.6	NA	Not reported	Not reported	Single value, not amenable to calculation of standard deviation

IMWG: Partial Response

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	3
Group 1b: Relapsed Myeloma	2

Values in ADC Ratio (follow-up / baseline) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Group 1a: New Myeloma	0.90	0.42	Not reported	Not reported	Not reported
Group 1b: Relapsed Myeloma	0.99	0.59	Not reported	Not reported	Not reported

IMWG: Very Good Partial Response

Analysis denominator · Participants

Group	Source count
Group 1a: New Myeloma	1
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	1.9	NA	Not reported	Not reported	Single value, not amenable to calculation of standard deviation

Complete source fields

classes

categories
measurements
comment
Single value, not amenable to calculation of standard deviation
group Id
OG000
spread
NA
value
1.6
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
IMWG: Progressive
categories
measurements
group Id
OG000
spread
0.42
value
0.90
group Id
OG001
spread
0.59
value
0.99
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
units
Participants
title
IMWG: Partial Response
categories
measurements
comment
Single value, not amenable to calculation of standard deviation
group Id
OG000
spread
NA
value
1.9
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
IMWG: Very Good Partial Response

denoms

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

description

dispersion Type

Standard Deviation

groups

description
Patients with new myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.
id
OG000
title
Group 1a: New Myeloma
description
Patients with relapsed myeloma who had a lytic bone lesion amenable to longitudinal ADC measurement, and IMWG response classification.
id
OG001
title
Group 1b: Relapsed Myeloma

param Type

MEAN

population Description

Participants who had successfully measured paired serum paraprotein (amenable to IMWG Response Group classification) and novel MR scans (with a lytic bone lesion amenable to ADC measurement, with a successfully calculated % change in ADC) at baseline and 6-month follow-up.

reporting Status

POSTED

time Frame

Comparison between baseline and follow-up at 6month

title

Secondary Outcome 1: Detect Longitudinal Changes in Tumour Load With Therapy [% Change in ADC (Apparent Diffusion Coefficient) vs IMWG (International Myeloma Working Group) Response Group Classification]

type

SECONDARY

unit Of Measure

ADC Ratio (follow-up / baseline)

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Preserved source evidence · Not medical advice