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NCT00325416 · OUTCOME

Phase I - Maximum Tolerated Dose (MTD) Level

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
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Phase I - 5 years, 2 months

What was measured

MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety. 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

Analysis population: Phase I Dose Escalation participants.

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 Rescue69
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue60

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue127.8Not reportedNot reportedNot reportedNot reported
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        127.8
      2. group Id
        OG001
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      60
    units
    Participants
description
MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety. 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
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
NUMBER
population Description
Phase I Dose Escalation participants.
reporting Status
POSTED
time Frame
Phase I - 5 years, 2 months
title
Phase I - Maximum Tolerated Dose (MTD) Level
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice