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NCT00450814 · OUTCOME

Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma · Source last updated 2019-12-16

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.

Analysis population: Per protocol, Phase I specified secondary endpoint is evaluated for each STAGE independently; thus, the stage 1 dose level groups were combined and the stage 2 dose level groups were combined for this analysis PER PROTOCOL.

Groups in this outcome

Phase I: Stage 1 (MV-NIS Alone)

Patients receive MV-NIS IV over 1 hour on day 1. (Closed to accrual on 12/17/2009 and reopened 10/13/2011)

Phase I: Stage 2 (MV-NIS and Cyclophosphamide)

Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then MV-NIS IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)

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

Analysis denominator · Participants

GroupSource count
Phase I: Stage 1 (MV-NIS Alone)21
Phase I: Stage 2 (MV-NIS and Cyclophosphamide)8

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: Stage 1 (MV-NIS Alone)38Not reportedNot reportedNot reportedNot reported
Phase I: Stage 2 (MV-NIS and Cyclophosphamide)25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      8
    units
    Participants
description
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.
groups
  1. description
    Patients receive MV-NIS IV over 1 hour on day 1. (Closed to accrual on 12/17/2009 and reopened 10/13/2011)
    id
    OG000
    title
    Phase I: Stage 1 (MV-NIS Alone)
  2. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then MV-NIS IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    OG001
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide)
param Type
NUMBER
population Description
Per protocol, Phase I specified secondary endpoint is evaluated for each STAGE independently; thus, the stage 1 dose level groups were combined and the stage 2 dose level groups were combined for this analysis PER PROTOCOL.
reporting Status
POSTED
time Frame
Up to 1 year
title
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice