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NCT03951220 · OUTCOME

Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Baseline 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 baseline

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 baseline 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 baseline, 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 Myeloma11
Group 1b: Relapsed Myeloma6

Reported measurements

Baseline ADC: Ongoing Chemotherapy

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma9
Group 1b: Relapsed Myeloma3
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1a: New Myeloma1084.5432.5Not reportedNot reportedNot reported
Group 1b: Relapsed Myeloma1215.3319.4Not reportedNot reportedNot reported
Baseline ADC: Recent (<1yr) Chemotherapy

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma0
Group 1b: Relapsed Myeloma3
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1b: Relapsed Myeloma751.7134.8Not reportedNot reportedNot reported
Baseline ADC: Never Chemotherapy

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma2
Group 1b: Relapsed Myeloma0
Values in s/mm^2 (ADC measurement unit) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1a: New Myeloma547.574.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        432.5
        value
        1084.5
      2. group Id
        OG001
        spread
        319.4
        value
        1215.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Baseline ADC: Ongoing Chemotherapy
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        134.8
        value
        751.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Baseline ADC: Recent (<1yr) Chemotherapy
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.2
        value
        547.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Baseline ADC: Never Chemotherapy
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      6
    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 baseline 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 baseline, with a lytic bone lesion identified amenable to ADC measurement.
reporting Status
POSTED
time Frame
At baseline
title
Post-Hoc Analysis: Relationship Between Intercurrent Chemotherapy and Baseline Magnetic Resonance (MR) Apparent Diffusion Coefficient (ADC) Measurements
type
POST_HOC
unit Of Measure
s/mm^2 (ADC measurement unit)

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

Preserved source evidence · Not medical advice