Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma

October 16, 2019 updated by: Celgene

Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 2
  • 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

  • Belgium
      • Gilly, Belgium, 6060
        • Hôpital St Joseph
      • Yvoir, Belgium, 5530
        • UCL de Mont Godine
  • France
      • Angers, France, 49100
        • Chu D'Angers - Medecine D
      • Annecy, France, 74011
        • Centre Hospitalier D'Annecy - Service d'oncohématologie
      • Avignon, France, 84902
        • Centre Hospitalier H. Duffaut - Hematologie
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ - Médecine interne/Hématologie
      • Blois, France, 41016
        • Centre Hospitalier de Blois - Unité d'Onco-Hématologie
      • Bobigny, France, 93009
        • Hopital Avicenne - Medecine Interne/Hematologie
      • Boulogne Sur Mer, France, 62321
        • Centre Hospitalier Du Dr Duschene - Hematologie
      • Brest, France, 29609
        • Hopital Morvan - Service Hematologie
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Caen, France, 14052
        • Polyclinique Du Parc - Hematologie
      • Chambery, France, 73011
        • Centre Hospitalier - Service Hematologie
      • Clamart, France, 92141
        • H.I.A. Percy Hematologie
      • Dunkerque, France, 59385
        • Centre Hospitalier General - Medecine Interne
      • Grenoble, France, 38043
        • Hopital Albert Michallon - Hematologie
      • La Roche Sur Yon, France, 85025
        • CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A
      • La Rochelle, France, 17019
        • Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale
      • Laval, France, 53015
        • Centre Hospitalier - Service de Médecine 7
      • Le Mans, France, 72015
        • Clinique Victor Hugo
      • Lille, France, 59037
        • CHRU CLAUDE HURIEZ - Maladies du sang
      • Lyon, France, 69437
        • Chu Edouard Herriot
      • Marseille, France, 13272
        • INSTITUT PAOLI CALMETTE - Unité transplantation
      • Metz, France, 57038
        • CHR Hôp N.D. de Bon Secours - Service de Médecine A
      • Montivilliers, France, 76290
        • Hopital Jacques Monod - Rhumatologie
      • Nantes, France, 44035
        • CHRU Hôtel Dieu, Service des Maladies du Sang
      • Nice, France, 06050
        • Centre Lacassagne
      • Paris, France, 75248
        • Institut Curie - Service d'hématologie
      • Paris, France, 75571
        • HOPITAL ST ANTOINE - Maladies du Sang
      • Perpignan, France, 66046
        • Centre Hospitalier Général - Service d'Hématologie
      • Pessac, France, 33604
        • Hopital Du Haut Leveque - Hematologie
      • Pierre Benite, France, 69945
        • Centre Hospitalier de Lyon Sud
      • Poitiers, France, 86021
        • CHRU Jean Bernard - Hématologie
      • Quimper, France, 29107
        • Centre Hospitalier Laennec - Service de Médecine A
      • Reims, France, 51032
        • Hôpital Robert Debré - Hématologie
      • Rennes, France, 35033
        • C.H.R. de Pontchaillou - Hématologie
      • Rennes, France, 35056
        • CHRU Hôpital Sud - Médecine Interne
      • Rouen, France, 76038
        • CENTRE HENRI BECQUEREL - Service Hématologie
      • Saint Etienne, France, 42055
        • C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie
      • Saint Etienne, France, 42055
        • Hôpital Nord - Hématologie
      • Strasbourg, France, 67000
        • CHU Hautepierre - Service Hématologie
      • Strasbourg, France, 67098
        • HOPITAL HAUTEPIERRE - Service Rhumatologie
      • Toulouse, France, 31054
        • C.H.U. Rangueil - Service Rhumatologie
      • Toulouse, France, 31059
        • C.H.U. PURPAN - Service Hématologie
      • Tours, France, 37044
        • C.H.U. Bretonneau
      • Tulle, France, 19012
        • Centre Hospitalier - Service de Rhumatologie
      • Valence, France, 26953
        • Centre Hospitalier - Hématologie
      • Vandoeuvre Les Nancy, France, 54511
        • CHU Hôpital Brabois - Médecine interne-Hématologie
      • Vannes, France, 56017
        • Centre Hospitalier Chubert - Médecine Interne

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient over 18 years who has been informed about the potential risks and side effects of the treatment and having signed an informed consent to take part in the various aspects of the study.
  • Having a refractory or relapsed multiple myeloma after at least two courses of treatment.
  • The patients with a refractory or relapsed multiple myeloma after a single course of treatment that included an alkylating drug, can be included if there is no alternative treatment.

  • Concerning the thalidomide: Agreement to use and introduction of effective contraception by all the patients:

    1. For women of childbearing potential

      • Oral estroprogestogen contraception introduced at least 1 month before the first administration of thalidomide, and continued until the first menstruation following the end of the treatment, and their partners use a condom.
      • Qualitative serum test for beta-HCG negative: to be done on Day 2 or 3 of the menstrual cycle just before the 1st prescription of thalidomide; in a context of spaniomenorrhea or amenorrhea the test should be done within 3 days after the 1st prescription of thalidomide.

    2. For post-menopausal women

      • 1st situation: Known sterility due to:

        • total hysterectomy;
        • total ovariectomy;
        • total salpingectomy

      • 2nd situation: Natural menopause

        • amenorrhea for at least 1 year and
        • negative progestagen test and
        • plasma FSH > 50 IU/l
    3. For men: Throughout the duration of the treatment and for 3 months after the end of the protocol (i.e. one spermatogenesis cycle), sexual intercourse must always be protected by using a condom.

Exclusion Criteria:

  • Pregnant or breast-feeding women or those of childbearing potential who are not using an effective method of contraception or the lack of protection during sexual intercourse in men.
  • Patients who have already received treatment with thalidomide.
  • Contraindication to thalidomide.
  • Patient who has an absolute contraindication to dexamethasone.
  • Patient with a history of deep vein thrombosis and who is not taking effective oral anticoagulation (the anticoagulant must be continued throughout the entire study).
  • Performance index more than or equal to 3, unless the patient is bedridden as a result of the progress of the myeloma.
  • Any situations that do not permit adequate follow-up of the study.

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
Experimental: A
Thalidomide 100mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Names:
  • THALOMID
Active Comparator: B
Thalidomide 400mg/day. Dexamethasone is administered at a dose of 40 mg/d, on 4 consecutive days (D1 - D4), with one course every four week in case of stable disease after 12 weeks of treatment or in case of Disease Progression
Drug: Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Other Names:
  • THALOMID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: monthly
monthly

Collaborators and Investigators

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

Sponsor

Celgene

Investigators

  • Principal Investigator: Ibrahim YAKOUB-AGHA, MD, CHRU Lille

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 (Actual)

December 1, 2001

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LATH0102/IFM0102

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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