Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00450814 · OUTCOME

Progression-free Survival (Phase II)

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
At 1 year

What was measured

1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Analysis population: Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.

Groups in this outcome

Phase II (Acetaminophen + Benadryl + MV-NIS)

Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.

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 II (Acetaminophen + Benadryl + MV-NIS)15

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II (Acetaminophen + Benadryl + MV-NIS)6.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6.7
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
groups
  1. description
    Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    OG000
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS)
param Type
NUMBER
population Description
Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.
reporting Status
POSTED
time Frame
At 1 year
title
Progression-free Survival (Phase II)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice