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NCT00450814 · OUTCOME

Maximum Tolerated Dose (MTD) (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
Dose Level
Interval / dispersion
Not reported
Time frame
6 weeks

What was measured

The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The MTD is reported below.

Analysis population: Only phase I stage 1 patients who completed the study are included in this analysis. Dose levels 1-6 of Phase I Stage 1 patients were combined in this analysis to determine the MTD as defined above.

Groups in this outcome

Phase I (Stage 1)

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

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)21

Reported measurements

Source class 1
Values in Dose Level · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I (Stage 1)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The MTD is reported below.
groups
  1. description
    Stage 1: 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)
param Type
NUMBER
population Description
Only phase I stage 1 patients who completed the study are included in this analysis. Dose levels 1-6 of Phase I Stage 1 patients were combined in this analysis to determine the MTD as defined above.
reporting Status
POSTED
time Frame
6 weeks
title
Maximum Tolerated Dose (MTD) (Phase I)
type
PRIMARY
unit Of Measure
Dose Level

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

Preserved source evidence · Not medical advice