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NCT01237054 · OUTCOME

Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM

Imaging in MGUS, SMM and MM · Source last updated 2026-02-06

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

Measure
MEDIAN
Unit
per min
Interval / dispersion
Full Range
Time frame
60 days

What was measured

Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

Analysis population: Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.

Groups in this outcome

MGUS (Monoclonal Gammopathy of Undetermined Significance)

MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.

SMM (Smoldering Multiple Myeloma)

Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.

MM (Multiple Myeloma)

Multiple myeloma is a plasma cell neoplasm.

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

Analysis denominator · Participants

GroupSource count
MGUS (Monoclonal Gammopathy of Undetermined Significance)10
SMM (Smoldering Multiple Myeloma)10
MM (Multiple Myeloma)7

Reported measurements

Kep
Values in per min · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)3.9Not reported1.69.2Not reported
SMM (Smoldering Multiple Myeloma)9Not reported0.712.2Not reported
MM (Multiple Myeloma)5.8Not reported2.112.7Not reported
Ktrans
Values in per min · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)2.4Not reported14.2Not reported
SMM (Smoldering Multiple Myeloma)2.3Not reported0.44.4Not reported
MM (Multiple Myeloma)3.1Not reported1.64.1Not 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
    non Inferiority Comment
    Other, trend test.
    non Inferiority Type
    OTHER
    p Value
    0.15
    p Value Comment
    The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.
    statistical Method
    Jonckheere-Terpstra test for trend
  2. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Comment
    Other, trend test.
    non Inferiority Type
    OTHER
    p Value
    0.33
    p Value Comment
    The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.
    statistical Method
    Jonckheere-Terpstra test for trend
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Comment
    Other, trend test.
    non Inferiority Type
    OTHER
    p Value
    0.15
    p Value Comment
    The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.
    statistical Method
    Jonckheere-Terpstra test for trend
  2. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Comment
    Other, trend test.
    non Inferiority Type
    OTHER
    p Value
    0.33
    p Value Comment
    The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.
    statistical Method
    Jonckheere-Terpstra test for trend
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        9.2
        value
        3.9
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        12.2
        value
        9
      3. group Id
        OG002
        lower Limit
        2.1
        upper Limit
        12.7
        value
        5.8
    title
    Kep
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        4.2
        value
        2.4
      2. group Id
        OG001
        lower Limit
        0.4
        upper Limit
        4.4
        value
        2.3
      3. group Id
        OG002
        lower Limit
        1.6
        upper Limit
        4.1
        value
        3.1
    title
    Ktrans
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
dispersion Type
Full Range
groups
  1. description
    MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
    id
    OG000
    title
    MGUS (Monoclonal Gammopathy of Undetermined Significance)
  2. description
    Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
    id
    OG001
    title
    SMM (Smoldering Multiple Myeloma)
  3. description
    Multiple myeloma is a plasma cell neoplasm.
    id
    OG002
    title
    MM (Multiple Myeloma)
param Type
MEDIAN
population Description
Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.
reporting Status
POSTED
time Frame
60 days
title
Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM
type
SECONDARY
unit Of Measure
per min

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Preserved source evidence · Not medical advice