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NCT01054196 · OUTCOME

Maximum Tolerated Dose (MTD) of Lenalidomide That Can be Added to Melphalan

Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study · Source last updated 2026-04-08

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

Measure
NUMBER
Unit
mg/day
Interval / dispersion
Not reported
Time frame
12 months

What was measured

The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan.

Analysis population: This outcome measure only assesses Phase 1 participants

Groups in this outcome

All Phase 1 Participants

All participants who received lenalidomide at 25mg daily x 5 days 25mg twice daily x 5 days 25mg qAM, 50mq qPM x 5 days 50mg qAM, 75mg qPM x 5 days 75mg qAM, 100mg qPM x 5 days 100mg qAM, 150mg qPM x 5 days 150mg qAM, 200mg qPM x 5 days

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

Analysis denominator · Participants

GroupSource count
All Phase 1 Participants21

Reported measurements

Source class 1
Values in mg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Phase 1 ParticipantsNANot reportedNot reportedNot reportedDespite administering HDLEN at doses of up to 350 mg/day, the maximum tolerated dose could not be determined, owing to an insufficient number of dose-limiting toxicities in the 21 patients enrolled in the trial
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Despite administering HDLEN at doses of up to 350 mg/day, the maximum tolerated dose could not be determined, owing to an insufficient number of dose-limiting toxicities in the 21 patients enrolled in the trial
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan.
groups
  1. description
    All participants who received lenalidomide at 25mg daily x 5 days 25mg twice daily x 5 days 25mg qAM, 50mq qPM x 5 days 50mg qAM, 75mg qPM x 5 days 75mg qAM, 100mg qPM x 5 days 100mg qAM, 150mg qPM x 5 days 150mg qAM, 200mg qPM x 5 days
    id
    OG000
    title
    All Phase 1 Participants
param Type
NUMBER
population Description
This outcome measure only assesses Phase 1 participants
reporting Status
POSTED
time Frame
12 months
title
Maximum Tolerated Dose (MTD) of Lenalidomide That Can be Added to Melphalan
type
PRIMARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice