Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma
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.
1 other identifier
interventional
400
2 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Dec 2001
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 7, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedOctober 18, 2019
October 1, 2019
3.8 years
April 7, 2008
October 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality
one year
Secondary Outcomes (1)
response rate
monthly
Study Arms (2)
A
EXPERIMENTALThalidomide 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
B
ACTIVE COMPARATORThalidomide 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
Interventions
Thalidomide 100mg/day or 400 mg/day at bed time during one year
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- For post-menopausal women
- st situation: Known sterility due to:
- total hysterectomy;
- total ovariectomy;
- total salpingectomy
- nd situation: Natural menopause
- amenorrhea for at least 1 year and
- negative progestagen test and
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (49)
Hopital St Joseph
Gilly, 6060, Belgium
UCL de Mont Godine
Yvoir, 5530, Belgium
Chu D'Angers - Medecine D
Angers, 49100, France
Centre Hospitalier D'Annecy - Service d'oncohématologie
Annecy, 74011, France
Centre Hospitalier H. Duffaut - Hematologie
Avignon, 84902, France
HOPITAL JEAN MINJOZ - Médecine interne/Hématologie
Besançon, 25030, France
Centre Hospitalier de Blois - Unité d'Onco-Hématologie
Blois, 41016, France
Hopital Avicenne - Medecine Interne/Hematologie
Bobigny, 93009, France
Centre Hospitalier Du Dr Duschene - Hematologie
Boulogne-sur-Mer, 62321, France
Hopital Morvan - Service Hematologie
Brest, 29609, France
Polyclinique Du Parc - Hematologie
Caen, 14052, France
Centre François Baclesse
Caen, 14076, France
Centre Hospitalier - Service Hematologie
Chambéry, 73011, France
H.I.A. Percy Hematologie
Clamart, 92141, France
Centre Hospitalier General - Medecine Interne
Dunkirk, 59385, France
Hopital Albert Michallon - Hematologie
Grenoble, 38043, France
CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A
La Roche-sur-Yon, 85025, France
Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale
La Rochelle, 17019, France
Centre Hospitalier - Service de Médecine 7
Laval, 53015, France
Clinique Victor Hugo
Le Mans, 72015, France
CHRU CLAUDE HURIEZ - Maladies du sang
Lille, 59037, France
Chu Edouard Herriot
Lyon, 69437, France
INSTITUT PAOLI CALMETTE - Unité transplantation
Marseille, 13272, France
CHR Hôp N.D. de Bon Secours - Service de Médecine A
Metz, 57038, France
Hopital Jacques Monod - Rhumatologie
Montivilliers, 76290, France
CHRU Hôtel Dieu, Service des Maladies du Sang
Nantes, 44035, France
Centre Lacassagne
Nice, 06050, France
Institut Curie - Service d'hématologie
Paris, 75248, France
HOPITAL ST ANTOINE - Maladies du Sang
Paris, 75571, France
Centre Hospitalier Général - Service d'Hématologie
Perpignan, 66046, France
Hopital Du Haut Leveque - Hematologie
Pessac, 33604, France
Centre Hospitalier de Lyon Sud
Pierre-Bénite, 69945, France
CHRU Jean Bernard - Hématologie
Poitiers, 86021, France
Centre Hospitalier Laennec - Service de Médecine A
Quimper, 29107, France
Hôpital Robert Debré - Hématologie
Reims, 51032, France
C.H.R. de Pontchaillou - Hématologie
Rennes, 35033, France
CHRU Hôpital Sud - Médecine Interne
Rennes, 35056, France
Centre Henri Becquerel - Service Hématologie
Rouen, 76038, France
C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie
Saint-Etienne, 42055, France
Hôpital Nord - Hématologie
Saint-Etienne, 42055, France
CHU Hautepierre - Service Hématologie
Strasbourg, 67000, France
HOPITAL HAUTEPIERRE - Service Rhumatologie
Strasbourg, 67098, France
C.H.U. Rangueil - Service Rhumatologie
Toulouse, 31054, France
C.H.U. PURPAN - Service Hématologie
Toulouse, 31059, France
C.H.U. Bretonneau
Tours, 37044, France
Centre Hospitalier - Service de Rhumatologie
Tulle, 19012, France
Centre Hospitalier - Hématologie
Valence, 26953, France
CHU Hôpital Brabois - Médecine interne-Hématologie
Vandœuvre-lès-Nancy, 54511, France
Centre Hospitalier Chubert - Médecine Interne
Vannes, 56017, France
Related 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 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.
PMID: 22023551BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ibrahim YAKOUB-AGHA, MD
CHRU LILLE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2008
First Posted
April 14, 2008
Study Start
December 1, 2001
Primary Completion
October 1, 2005
Study Completion
April 1, 2006
Last Updated
October 18, 2019
Record last verified: 2019-10