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NCT03951220 · OUTCOME

Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Follow-Up Magnetic Resonance (MR) Apparent Diffusion Coefficient (ADC) Measurements

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
s/mm^2 (ADC measurement unit)
Interval / dispersion
Standard Deviation
Time frame
At follow-up

What was measured

We first addressed an important practical limitation of the study design. Patients with new myeloma usually commenced chemotherapy imminently after their diagnosis, typically a few months before they were able to consent for the present study. Therefore, most patients had already started chemotherapy at the point of baseline novel Magnetic Resonance (MR) scan, and had received variable durations of chemotherapy at baseline and follow-up scans. We hypothesised that this may be a potential confounding factor, as more recent chemotherapy may reduce tumour cellularity and therefore increase diffusion \[and therefore Apparent Diffusion Coefficient (ADC) measurements\] at lytic bone lesions. In this particular section, we analysed the difference between follow-up ADC measurements in patients with new and relapsed myeloma, grouped by time elapsed since chemotherapy (ongoing, recent or never chemotherapy).

Analysis population: Analysis included patients from Groups 1a and 1b who had a novel MR scan at follow-up, with a lytic bone lesion identified amenable to ADC measurement.

Groups in this outcome

Group 1a: New Myeloma

All patients with new myeloma at recruitment.

Group 1b: Relapsed Myeloma

All patients with relapsed myeloma at recruitment.

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

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma6
Group 1b: Relapsed Myeloma4

Reported measurements

Follow-Up ADC: Ongoing Chemotherapy

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma2
Group 1b: Relapsed Myeloma2
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1a: New Myeloma1875205Not reportedNot reportedNot reported
Group 1b: Relapsed Myeloma1415968.7Not reportedNot reportedNot reported
Follow-Up ADC: Recent (<1yr) Chemotherapy

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma4
Group 1b: Relapsed Myeloma1
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1a: New Myeloma1252.3634.7Not reportedNot reportedNot reported
Group 1b: Relapsed Myeloma900Not reportedNot reportedNot reportedNot reported
Follow-Up ADC: Historic Chemotherapy (>1yr)

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma0
Group 1b: Relapsed Myeloma1
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1b: Relapsed Myeloma648Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        205
        value
        1875
      2. group Id
        OG001
        spread
        968.7
        value
        1415
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Follow-Up ADC: Ongoing Chemotherapy
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        634.7
        value
        1252.3
      2. group Id
        OG001
        value
        900
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Follow-Up ADC: Recent (<1yr) Chemotherapy
  3. categories
    1. measurements
      1. group Id
        OG001
        value
        648
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Follow-Up ADC: Historic Chemotherapy (>1yr)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    units
    Participants
description
We first addressed an important practical limitation of the study design. Patients with new myeloma usually commenced chemotherapy imminently after their diagnosis, typically a few months before they were able to consent for the present study. Therefore, most patients had already started chemotherapy at the point of baseline novel Magnetic Resonance (MR) scan, and had received variable durations of chemotherapy at baseline and follow-up scans. We hypothesised that this may be a potential confounding factor, as more recent chemotherapy may reduce tumour cellularity and therefore increase diffusion \[and therefore Apparent Diffusion Coefficient (ADC) measurements\] at lytic bone lesions. In this particular section, we analysed the difference between follow-up ADC measurements in patients with new and relapsed myeloma, grouped by time elapsed since chemotherapy (ongoing, recent or never chemotherapy).
dispersion Type
Standard Deviation
groups
  1. description
    All patients with new myeloma at recruitment.
    id
    OG000
    title
    Group 1a: New Myeloma
  2. description
    All patients with relapsed myeloma at recruitment.
    id
    OG001
    title
    Group 1b: Relapsed Myeloma
param Type
MEAN
population Description
Analysis included patients from Groups 1a and 1b who had a novel MR scan at follow-up, with a lytic bone lesion identified amenable to ADC measurement.
reporting Status
POSTED
time Frame
At follow-up
title
Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Follow-Up Magnetic Resonance (MR) Apparent Diffusion Coefficient (ADC) Measurements
type
POST_HOC
unit Of Measure
s/mm^2 (ADC measurement unit)

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Preserved source evidence · Not medical advice