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NCT03870451 · OUTCOME

NCI-CTCAE v5.0 Severity Grade Changes

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma · Source last updated 2026-10-13

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline, 4 weeks, 8 weeks

What was measured

Physician graded assessment of peripheral neuropathy as measured by NCI-CTCAE v5.0 criteria. The CTCAE displays Grades 1 through 5 (1 = mild, 5 = death)

Analysis population: The number of patients differs slightly by visit due to missed visits creating missing data

Groups in this outcome

Grade 2-3 Established Neuropathy

VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device

Grade 1-2 New-onset Neuropathy

VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device

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

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy12
Grade 1-2 New-onset Neuropathy6

Reported measurements

Baseline - Grade 1 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy12
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy1Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy1Not reportedNot reportedNot reportedNot reported
Baseline - Grade 2 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy12
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy8Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy5Not reportedNot reportedNot reportedNot reported
Baseline - Grade 3 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy12
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy3Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy0Not reportedNot reportedNot reportedNot reported
Week 4 - Grade 1 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy8
Grade 1-2 New-onset Neuropathy5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy1Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy0Not reportedNot reportedNot reportedNot reported
Week 4 - Grade 2 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy8
Grade 1-2 New-onset Neuropathy5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy7Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy5Not reportedNot reportedNot reportedNot reported
Week 4 - Grade 3 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy8
Grade 1-2 New-onset Neuropathy5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy0Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy0Not reportedNot reportedNot reportedNot reported
Week 8 - Grade 1 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy10
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy2Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy2Not reportedNot reportedNot reportedNot reported
Week 8 - Grade 2 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy10
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy5Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy4Not reportedNot reportedNot reportedNot reported
Week 8 - Grade 3 Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Grade 2-3 Established Neuropathy10
Grade 1-2 New-onset Neuropathy6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2-3 Established Neuropathy3Not reportedNot reportedNot reportedNot reported
Grade 1-2 New-onset Neuropathy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Baseline - Grade 1 Peripheral Neuropathy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Baseline - Grade 2 Peripheral Neuropathy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Baseline - Grade 3 Peripheral Neuropathy
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Week 4 - Grade 1 Peripheral Neuropathy
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Week 4 - Grade 2 Peripheral Neuropathy
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Week 4 - Grade 3 Peripheral Neuropathy
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Week 8 - Grade 1 Peripheral Neuropathy
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Week 8 - Grade 2 Peripheral Neuropathy
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Week 8 - Grade 3 Peripheral Neuropathy
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Physician graded assessment of peripheral neuropathy as measured by NCI-CTCAE v5.0 criteria. The CTCAE displays Grades 1 through 5 (1 = mild, 5 = death)
groups
  1. description
    VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
    id
    OG000
    title
    Grade 2-3 Established Neuropathy
  2. description
    VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
    id
    OG001
    title
    Grade 1-2 New-onset Neuropathy
param Type
NUMBER
population Description
The number of patients differs slightly by visit due to missed visits creating missing data
reporting Status
POSTED
time Frame
Baseline, 4 weeks, 8 weeks
title
NCI-CTCAE v5.0 Severity Grade Changes
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice