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Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma

NCT00452569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2019-11-18

No results posted yet for this study

Summary

The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

Conditions

Interventions

DRUG

Thalidomide

Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days).

DRUG

Dexamethasone

High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Martin Kropff, MD · Universitatsklinikum Munster

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-01
Primary Completion
2008-12-01
Completion
2009-01-01

Countries

  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Philippines
  • Poland
  • Portugal
  • Serbia
  • Slovakia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452569 on ClinicalTrials.gov