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NCT00325416 · OUTCOME

Phase II Overall Survival (OS)

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. · Source last updated 2018-03-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Phase II - Phase start at 62 months up to 120 months

What was measured

Time from start of treatment until death from any cause.

Analysis population: Phase II (treatment at MTD) evaluable participants at time of analysis

Groups in this outcome

Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue

Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue

Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

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

Analysis denominator · Participants

GroupSource count
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue39
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue40

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue63Not reported35NAnot yet reached
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue62Not reported45NAnot yet reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        not yet reached
        group Id
        OG000
        lower Limit
        35
        upper Limit
        NA
        value
        63
      2. comment
        not yet reached
        group Id
        OG001
        lower Limit
        45
        upper Limit
        NA
        value
        62
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Time from start of treatment until death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    OG000
    title
    Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
  2. description
    Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    OG001
    title
    Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
param Type
MEDIAN
population Description
Phase II (treatment at MTD) evaluable participants at time of analysis
reporting Status
POSTED
time Frame
Phase II - Phase start at 62 months up to 120 months
title
Phase II Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice