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NCT00112827 · OUTCOME

Maximum Tolerated Dose (MTD)

Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma · Source last updated 2025-06-06

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

Measure
NUMBER
Unit
cGy
Interval / dispersion
Not reported
Time frame
8 weeks from start of treatment, up to 2 years

What was measured

The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.

Analysis population: All patients enrolled in the dose-finding portion of the study.

Groups in this outcome

Treatment Arm

See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally

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

Analysis denominator · Participants

GroupSource count
Treatment Arm24

Reported measurements

Source class 1
Values in cGy · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1600Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1600
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.
groups
  1. description
    See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
    id
    OG000
    title
    Treatment Arm
param Type
NUMBER
population Description
All patients enrolled in the dose-finding portion of the study.
reporting Status
POSTED
time Frame
8 weeks from start of treatment, up to 2 years
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
cGy

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

Preserved source evidence · Not medical advice