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NCT01242267 · OUTCOME

Toxicity Assessment

Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT · Source last updated 2026-04-02

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

Measure
NUMBER
Unit
Serious Adverse Events
Interval / dispersion
Not reported
Time frame
Patients will be hospitalized or in the outpatient transplant facility until engraftment and resolution of serious adverse events, a median of 16 (range, 11-24) days

What was measured

Assessment of the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan

Groups in this outcome

Phase I - Thalidomide Dose Level 600 mg

Phase I - Thalidomide Dose Level 600 mg

Phase I - Thalidomide Dose Level 800 mg

Phase I - Thalidomide Dose Level 800 mg

Phase I - Thalidomide Dose Level 1000 mg

Phase I - Thalidomide Dose Level 1000 mg

Phase 2

Phase 2 Dose Level 1000 mg of Thalidomide

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 - Thalidomide Dose Level 600 mg3
Phase I - Thalidomide Dose Level 800 mg3
Phase I - Thalidomide Dose Level 1000 mg3
Phase 220

Reported measurements

Source class 1
Values in Serious Adverse Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - Thalidomide Dose Level 600 mg1Not reportedNot reportedNot reportedNot reported
Phase I - Thalidomide Dose Level 800 mg0Not reportedNot reportedNot reportedNot reported
Phase I - Thalidomide Dose Level 1000 mg0Not reportedNot reportedNot reportedNot reported
Phase 23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      20
    units
    Participants
description
Assessment of the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan
groups
  1. description
    Phase I - Thalidomide Dose Level 600 mg
    id
    OG000
    title
    Phase I - Thalidomide Dose Level 600 mg
  2. description
    Phase I - Thalidomide Dose Level 800 mg
    id
    OG001
    title
    Phase I - Thalidomide Dose Level 800 mg
  3. description
    Phase I - Thalidomide Dose Level 1000 mg
    id
    OG002
    title
    Phase I - Thalidomide Dose Level 1000 mg
  4. description
    Phase 2 Dose Level 1000 mg of Thalidomide
    id
    OG003
    title
    Phase 2
param Type
NUMBER
reporting Status
POSTED
time Frame
Patients will be hospitalized or in the outpatient transplant facility until engraftment and resolution of serious adverse events, a median of 16 (range, 11-24) days
title
Toxicity Assessment
type
SECONDARY
unit Of Measure
Serious Adverse Events

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

Preserved source evidence · Not medical advice