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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00657488
First received: April 7, 2008
Last updated: September 22, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2001
Study Completion Date: April 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: THALOMID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657488

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

No publications provided

Responsible Party: Robert Zerbib, Manager Clinical Programs, Pharmion
ClinicalTrials.gov Identifier: NCT00657488     History of Changes
Other Study ID Numbers: LATH0102/IFM0102
Study First Received: April 7, 2008
Last Updated: September 22, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Celgene Corporation:
Multiple Myeloma, Thalidomide, dose, dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Thalidomide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014