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NCT01237054 · OUTCOME

Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups

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
MEAN
Unit
pg/ml
Interval / dispersion
Standard Error
Time frame
60 days

What was measured

The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.

Analysis population: Serum was not available for three patients in the SMM group.

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)/MM (Multiple Myeloma)

Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder. 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)/MM (Multiple Myeloma)17

Reported measurements

Ang2 (angiopoietin)
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)2465.97589.27Not reportedNot reportedNot reported
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)3804.42467.16Not reportedNot reportedNot reported
G-CSF (granulocyte-colony stimulating factor)
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)24.9211.66Not reportedNot reportedNot reported
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)101.0842.81Not reportedNot reportedNot reported
Follistatin
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)562.4588.89Not reportedNot reportedNot reported
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)823.1583.00Not reportedNot reportedNot reported
HGF (hepatocyte growth factor)
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)390.5770.82Not reportedNot reportedNot reported
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)654.3457.97Not reportedNot reportedNot reported
VEGF-A (vascular endothelial growth factor-A)
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)844.31435.94Not reportedNot reportedNot reported
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)1301.52196.47Not reportedNot reportedNot reported
FGF-1 (fibroblast growth factor 1)
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)NANANot reportedNot reportedSerum measures of FGF-1 were below the range of detectability, so these markers were excluded from analysis.
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)NANANot reportedNot reportedSerum measures of FGF-1 were below the range of detectability, so these markers were excluded from analysis.
Endothelin 1
Values in pg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
MGUS (Monoclonal Gammopathy of Undetermined Significance)NANANot reportedNot reportedSerum measures of endothelin-1 were below the range of detectability, so these markers were excluded from analysis.
SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)NANANot reportedNot reportedSerum measures of endothelin-1 were below the range of detectability, so these markers were excluded from analysis.

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.024
    p Value Comment
    The reported p-value is representative of the difference in levels of Ang2 in both groups.
    statistical Method
    Wilcoxon rank sum test
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.055
    p Value Comment
    The reported p-value is representative of the difference in levels of G-CSF in both groups.
    statistical Method
    Wilcoxon rank sum test
  3. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.055
    p Value Comment
    The reported p-value is representative of the difference in levels of Follistatin in both groups.
    statistical Method
    Wilcoxon rank sum test
  4. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0098
    p Value Comment
    The reported p-value is representative of the difference in levels of HGF in both groups.
    statistical Method
    Wilcoxon rank sum test
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the difference in levels of VEGF-A in both groups.
    statistical Method
    Wilcoxon rank sum test
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.024
    p Value Comment
    The reported p-value is representative of the difference in levels of Ang2 in both groups.
    statistical Method
    Wilcoxon rank sum test
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.055
    p Value Comment
    The reported p-value is representative of the difference in levels of G-CSF in both groups.
    statistical Method
    Wilcoxon rank sum test
  3. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.055
    p Value Comment
    The reported p-value is representative of the difference in levels of Follistatin in both groups.
    statistical Method
    Wilcoxon rank sum test
  4. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0098
    p Value Comment
    The reported p-value is representative of the difference in levels of HGF in both groups.
    statistical Method
    Wilcoxon rank sum test
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the difference in levels of VEGF-A in both groups.
    statistical Method
    Wilcoxon rank sum test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        589.27
        value
        2465.97
      2. group Id
        OG001
        spread
        467.16
        value
        3804.42
    title
    Ang2 (angiopoietin)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.66
        value
        24.92
      2. group Id
        OG001
        spread
        42.81
        value
        101.08
    title
    G-CSF (granulocyte-colony stimulating factor)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        88.89
        value
        562.45
      2. group Id
        OG001
        spread
        83.00
        value
        823.15
    title
    Follistatin
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.82
        value
        390.57
      2. group Id
        OG001
        spread
        57.97
        value
        654.34
    title
    HGF (hepatocyte growth factor)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        435.94
        value
        844.31
      2. group Id
        OG001
        spread
        196.47
        value
        1301.52
    title
    VEGF-A (vascular endothelial growth factor-A)
  6. categories
    1. measurements
      1. comment
        Serum measures of FGF-1 were below the range of detectability, so these markers were excluded from analysis.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Serum measures of FGF-1 were below the range of detectability, so these markers were excluded from analysis.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    FGF-1 (fibroblast growth factor 1)
  7. categories
    1. measurements
      1. comment
        Serum measures of endothelin-1 were below the range of detectability, so these markers were excluded from analysis.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Serum measures of endothelin-1 were below the range of detectability, so these markers were excluded from analysis.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    Endothelin 1
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      17
    units
    Participants
description
The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.
dispersion Type
Standard Error
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. Multiple myeloma is a plasma cell neoplasm.
    id
    OG001
    title
    SMM (Smoldering Multiple Myeloma)/MM (Multiple Myeloma)
param Type
MEAN
population Description
Serum was not available for three patients in the SMM group.
reporting Status
POSTED
time Frame
60 days
title
Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups
type
SECONDARY
unit Of Measure
pg/ml

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Preserved source evidence · Not medical advice