Clinical trial NCT00657488: Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Thalidomide, dose, dexamethasone
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: response rate
timeFrame: monthly
Other outcomes:
Locations:
city: Gilly
country: Belgium
facility: Hopital St Joseph
city: Yvoir
country: Belgium
facility: UCL de Mont Godine
city: Angers
country: France
facility: Chu D'Angers - Medecine D
city: Annecy
country: France
facility: Centre Hospitalier D'Annecy - Service d'oncohématologie
city: Avignon
country: France
facility: Centre Hospitalier H. Duffaut - Hematologie
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ - Médecine interne/Hématologie
city: Blois
country: France
facility: Centre Hospitalier de Blois - Unité d'Onco-Hématologie
city: Bobigny
country: France
facility: Hopital Avicenne - Medecine Interne/Hematologie
city: Boulogne Sur Mer
country: France
facility: Centre Hospitalier Du Dr Duschene - Hematologie
city: Brest
country: France
facility: Hopital Morvan - Service Hematologie
city: Caen
country: France
facility: Polyclinique Du Parc - Hematologie
city: Caen
country: France
facility: Centre François Baclesse
city: Chambery
country: France
facility: Centre Hospitalier - Service Hematologie
city: Clamart
country: France
facility: H.I.A. Percy Hematologie
city: Dunkerque
country: France
facility: Centre Hospitalier General - Medecine Interne
city: Grenoble
country: France
facility: Hopital Albert Michallon - Hematologie
city: La Roche Sur Yon
country: France
facility: CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale
city: Laval
country: France
facility: Centre Hospitalier - Service de Médecine 7
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: CHRU CLAUDE HURIEZ - Maladies du sang
city: Lyon
country: France
facility: Chu Edouard Herriot
city: Marseille
country: France
facility: INSTITUT PAOLI CALMETTE - Unité transplantation
city: Metz
country: France
facility: CHR Hôp N.D. de Bon Secours - Service de Médecine A
city: Montivilliers
country: France
facility: Hopital Jacques Monod - Rhumatologie
city: Nantes
country: France
facility: CHRU Hôtel Dieu, Service des Maladies du Sang
city: Nice
country: France
facility: Centre Lacassagne
city: Paris
country: France
facility: Institut Curie - Service d'hématologie
city: Paris
country: France
facility: HOPITAL ST ANTOINE - Maladies du Sang
city: Perpignan
country: France
facility: Centre Hospitalier Général - Service d'Hématologie
city: Pessac
country: France
facility: Hopital Du Haut Leveque - Hematologie
city: Pierre Benite
country: France
facility: Centre Hospitalier de Lyon Sud
city: Poitiers
country: France
facility: CHRU Jean Bernard - Hématologie
city: Quimper
country: France
facility: Centre Hospitalier Laennec - Service de Médecine A
city: Reims
country: France
facility: Hôpital Robert Debré - Hématologie
city: Rennes
country: France
facility: C.H.R. de Pontchaillou - Hématologie
city: Rennes
country: France
facility: CHRU Hôpital Sud - Médecine Interne
city: Rouen
country: France
facility: Centre Henri Becquerel - Service Hématologie
city: Saint Etienne
country: France
facility: C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie
city: Saint Etienne
country: France
facility: Hôpital Nord - Hématologie
city: Strasbourg
country: France
facility: CHU Hautepierre - Service Hématologie
city: Strasbourg
country: France
facility: HOPITAL HAUTEPIERRE - Service Rhumatologie
city: Toulouse
country: France
facility: C.H.U. Rangueil - Service Rhumatologie
city: Toulouse
country: France
facility: C.H.U. PURPAN - Service Hématologie
city: Tours
country: France
facility: C.H.U. Bretonneau
city: Tulle
country: France
facility: Centre Hospitalier - Service de Rhumatologie
city: Valence
country: France
facility: Centre Hospitalier - Hématologie
city: Vandoeuvre Les Nancy
country: France
facility: CHU Hôpital Brabois - Médecine interne-Hématologie
city: Vannes
country: France
facility: Centre Hospitalier Chubert - Médecine Interne
Study officials:
affiliation: CHRU LILLE
name: Ibrahim YAKOUB-AGHA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakoub-Agha I, Mary JY, Hulin C, Doyen C, Marit G, Benboubker L, Voillat L, Moreau P, Berthou C, Stoppa AM, Maloisel F, Rodon P, Dib M, Pegourie B, Casassus P, Slama B, Damaj G, Zerbib R, Harousseau JL, Mohty M, Facon T; Intergroupe Francophone du Myelome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myelome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4.