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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 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Comparison between baseline and follow-up at 6 months.

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. 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 \[2\]. 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 from Group 1 who had successfully measured paired novel MR scans and serum paraproteins, between baseline and 6-month follow-up, and with a successfully graded MY-RADS RAC, and IMWG Response Group classifications.

Groups in this outcome

IMWG: Relapse

IMWG classification of therapy response

IMWG: Progressive

IMWG classification of therapy response

IMWG: Stable

IMWG classification of therapy response

IMWG: Partial Response

IMWG classification of therapy response

IMWG: Very Good Partial Response

IMWG classification of therapy response

IMWG: Complete Response

IMWG classification of therapy response

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

Analysis denominator · Participants

GroupSource count
IMWG: Relapse1
IMWG: Progressive4
IMWG: Stable8
IMWG: Partial Response9
IMWG: Very Good Partial Response4
IMWG: Complete Response1

Reported measurements

Source class 1

MY-RADS RAC 1: Highly likely to be responding

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMWG: Relapse0Not reportedNot reportedNot reportedNot reported
IMWG: Progressive0Not reportedNot reportedNot reportedNot reported
IMWG: Stable0Not reportedNot reportedNot reportedNot reported
IMWG: Partial Response2Not reportedNot reportedNot reportedNot reported
IMWG: Very Good Partial Response3Not reportedNot reportedNot reportedNot reported
IMWG: Complete Response0Not reportedNot reportedNot reportedNot reported

MY-RADS RAC 2: Likely to be responding

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMWG: Relapse0Not reportedNot reportedNot reportedNot reported
IMWG: Progressive1Not reportedNot reportedNot reportedNot reported
IMWG: Stable0Not reportedNot reportedNot reportedNot reported
IMWG: Partial Response4Not reportedNot reportedNot reportedNot reported
IMWG: Very Good Partial Response0Not reportedNot reportedNot reportedNot reported
IMWG: Complete Response0Not reportedNot reportedNot reportedNot reported

MY-RADS RAC 3: Stable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMWG: Relapse1Not reportedNot reportedNot reportedNot reported
IMWG: Progressive3Not reportedNot reportedNot reportedNot reported
IMWG: Stable8Not reportedNot reportedNot reportedNot reported
IMWG: Partial Response3Not reportedNot reportedNot reportedNot reported
IMWG: Very Good Partial Response1Not reportedNot reportedNot reportedNot reported
IMWG: Complete Response1Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    5. OG004
    6. OG005
    non Inferiority Type
    OTHER
    p Value
    0.015
    statistical Method
    Fisher-Freeman-Halton exact test
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    5. OG004
    6. OG005
    non Inferiority Type
    OTHER
    p Value
    0.015
    statistical Method
    Fisher-Freeman-Halton exact test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        0
      title
      MY-RADS RAC 1: Highly likely to be responding
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      title
      MY-RADS RAC 2: Likely to be responding
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      title
      MY-RADS RAC 3: Stable
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      1
    units
    Participants
description
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. 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 \[2\]. 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.
groups
  1. description
    IMWG classification of therapy response
    id
    OG000
    title
    IMWG: Relapse
  2. description
    IMWG classification of therapy response
    id
    OG001
    title
    IMWG: Progressive
  3. description
    IMWG classification of therapy response
    id
    OG002
    title
    IMWG: Stable
  4. description
    IMWG classification of therapy response
    id
    OG003
    title
    IMWG: Partial Response
  5. description
    IMWG classification of therapy response
    id
    OG004
    title
    IMWG: Very Good Partial Response
  6. description
    IMWG classification of therapy response
    id
    OG005
    title
    IMWG: Complete Response
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants from Group 1 who had successfully measured paired novel MR scans and serum paraproteins, between baseline and 6-month follow-up, and with a successfully graded MY-RADS RAC, and IMWG Response Group classifications.
reporting Status
POSTED
time Frame
Comparison between baseline and follow-up at 6 months.
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 IMWG (International Myeloma Working Group) Response Group Classification]
type
SECONDARY
unit Of Measure
Participants

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