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

NCT ID: NCT00657488

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-01
• Study Completion Date: 2006-04-01

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Thalidomide

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Thalidomide

Intervention Type: DRUG

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

Interventions

Thalidomide

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

Intervention Type: DRUG

Other Intervention Names

THALOMID

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ibrahim YAKOUB-AGHA, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Locations

Hopital St Joseph

Gilly, , Belgium

UCL de Mont Godine

Yvoir, , Belgium

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

Besançon, , 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

Polyclinique Du Parc - Hematologie

Caen, , France

Centre François Baclesse

Caen, , France

Centre Hospitalier - Service Hematologie

Chambéry, , France

H.I.A. Percy Hematologie

Clamart, , France

Centre Hospitalier General - Medecine Interne

Dunkirk, , 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

Institut Curie - Service d'hématologie

Paris, , France

HOPITAL ST ANTOINE - Maladies du Sang

Paris, , France

Centre Hospitalier Général - Service d'Hématologie

Perpignan, , France

Hopital Du Haut Leveque - Hematologie

Pessac, , France

Centre Hospitalier de Lyon Sud

Pierre-Bénite, , 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. Rangueil - Service Rhumatologie

Toulouse, , France

C.H.U. PURPAN - Service Hématologie

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

Vandœuvre-lès-Nancy, , France

Centre Hospitalier Chubert - Médecine Interne

Vannes, , France

Countries

Belgium; France

References

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.

Reference Type: BACKGROUND

PMID: 22023551 (View on PubMed)

Other Identifiers

LATH0102/IFM0102

Identifier Type: -

Identifier Source: org_study_id