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

Multiple Myeloma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657488
• Other study ID #: LATH0102/IFM0102
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2001
• Est. completion date: April 1, 2006

Study information

• Verified date: October 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 1, 2006
• Est. primary completion date: October 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Thalidomide
Thalidomide 100mg/day or 400 mg/day at bed time during one year

Locations

Country	Name	City	State
Belgium	Hopital St Joseph	Gilly
Belgium	UCL de Mont Godine	Yvoir
France	Chu D'Angers - Medecine D	Angers
France	Centre Hospitalier D'Annecy - Service d'oncohématologie	Annecy
France	Centre Hospitalier H. Duffaut - Hematologie	Avignon
France	HOPITAL JEAN MINJOZ - Médecine interne/Hématologie	Besancon
France	Centre Hospitalier de Blois - Unité d'Onco-Hématologie	Blois
France	Hopital Avicenne - Medecine Interne/Hematologie	Bobigny
France	Centre Hospitalier Du Dr Duschene - Hematologie	Boulogne Sur Mer
France	Hopital Morvan - Service Hematologie	Brest
France	Centre François Baclesse	Caen
France	Polyclinique Du Parc - Hematologie	Caen
France	Centre Hospitalier - Service Hematologie	Chambery
France	H.I.A. Percy Hematologie	Clamart
France	Centre Hospitalier General - Medecine Interne	Dunkerque
France	Hopital Albert Michallon - Hematologie	Grenoble
France	CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A	La Roche Sur Yon
France	Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale	La Rochelle
France	Centre Hospitalier - Service de Médecine 7	Laval
France	Clinique Victor Hugo	Le Mans
France	CHRU CLAUDE HURIEZ - Maladies du sang	Lille
France	Chu Edouard Herriot	Lyon
France	INSTITUT PAOLI CALMETTE - Unité transplantation	Marseille
France	CHR Hôp N.D. de Bon Secours - Service de Médecine A	Metz
France	Hopital Jacques Monod - Rhumatologie	Montivilliers
France	CHRU Hôtel Dieu, Service des Maladies du Sang	Nantes
France	Centre Lacassagne	Nice
France	HOPITAL ST ANTOINE - Maladies du Sang	Paris
France	Institut Curie - Service d'hématologie	Paris
France	Centre Hospitalier Général - Service d'Hématologie	Perpignan
France	Hopital Du Haut Leveque - Hematologie	Pessac
France	Centre Hospitalier de Lyon Sud	Pierre Benite
France	CHRU Jean Bernard - Hématologie	Poitiers
France	Centre Hospitalier Laennec - Service de Médecine A	Quimper
France	Hôpital Robert Debré - Hématologie	Reims
France	C.H.R. de Pontchaillou - Hématologie	Rennes
France	CHRU Hôpital Sud - Médecine Interne	Rennes
France	Centre Henri Becquerel - Service Hématologie	Rouen
France	C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie	Saint Etienne
France	Hôpital Nord - Hématologie	Saint Etienne
France	CHU Hautepierre - Service Hématologie	Strasbourg
France	HOPITAL HAUTEPIERRE - Service Rhumatologie	Strasbourg
France	C.H.U. PURPAN - Service Hématologie	Toulouse
France	C.H.U. Rangueil - Service Rhumatologie	Toulouse
France	C.H.U. Bretonneau	Tours
France	Centre Hospitalier - Service de Rhumatologie	Tulle
France	Centre Hospitalier - Hématologie	Valence
France	CHU Hôpital Brabois - Médecine interne-Hématologie	Vandoeuvre Les Nancy
France	Centre Hospitalier Chubert - Médecine Interne	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

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 Myélome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myélome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year
Secondary	response rate		monthly