Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00450814 · OUTCOME

Number of Patients With Clinical Responses (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

The number of patients with clinical responses (CR, VGPR, PR, or minimal response \[MR\]) will be summarized by stage.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: Stage 1 (MV-NIS Alone)1Not reportedNot reportedNot reportedNot reported
Phase I: Stage 2 (MV-NIS and Cyclophosphamide)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      8
    units
    Participants
description
The number of patients with clinical responses (CR, VGPR, PR, or minimal response \[MR\]) will be summarized by stage.
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
COUNT_OF_PARTICIPANTS
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
Number of Patients With Clinical Responses (Phase I)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice