IFM 99-02 Thalidomide in Myeloma

April 1, 2010 updated by: University Hospital, Toulouse
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Médecine Interne, CHU Purpan
      • Toulouse, France
        • Médecine Interne, Hôpital Rangueil
      • Toulouse, France
        • Rhumatologie, CHU Purpan
      • Toulouse, France
        • Rhumatologie, CHU Rangueil
      • Toulouse, France
        • Service d'hématologie, CHU Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • de novo myeloma
  • according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
  • patients from 18 to 65 years old
  • beta2microglobulin < 3 mg/l or del13 absent
  • signed informed consent
  • eligible for transplantation

Exclusion Criteria:

  • peripheral neurological toxicities
  • uncontrolled or severe cardiovascular disease
  • other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
  • patient who received biphosphonate during the last 60 days
  • renal failure definited as creatinine > 150 µmol/l
  • patient with obvious vascular cerebral medical history
  • liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
  • respiratory dysfunction
  • HIV +
  • Patient who refused to use an acceptable barrier method for contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
No specific intervention
Active Comparator: 2
Biphosphonates
Drug: Biphosphonates
Biphosphonates
Experimental: 3
Thalidomide
Drug: Thalidomide
Per os thalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 3 years
3 years
Toxicity
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: ATTAL Michel, MD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 98-45-N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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