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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00657488

Collaborator

(none)

400

Enrollment

Locations

Arms

Actual Duration (Months)

8.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Thalidomide	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Actual Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: THALOMID

Arm

Intervention/Treatment

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 Names:

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 Names:

THALOMID

Outcome Measures

Primary Outcome Measures

all cause mortality [one year]

Secondary Outcome Measures

response rate [monthly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

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

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

Locations

	Site	City	Country	Postal Code
1	Hopital St Joseph	Gilly	Belgium	6060
2	UCL de Mont Godine	Yvoir	Belgium	5530
3	Chu D'Angers - Medecine D	Angers	France	49100
4	Centre Hospitalier D'Annecy - Service d'oncohématologie	Annecy	France	74011
5	Centre Hospitalier H. Duffaut - Hematologie	Avignon	France	84902
6	HOPITAL JEAN MINJOZ - Médecine interne/Hématologie	Besancon	France	25030
7	Centre Hospitalier de Blois - Unité d'Onco-Hématologie	Blois	France	41016
8	Hopital Avicenne - Medecine Interne/Hematologie	Bobigny	France	93009
9	Centre Hospitalier Du Dr Duschene - Hematologie	Boulogne Sur Mer	France	62321
10	Hopital Morvan - Service Hematologie	Brest	France	29609
11	Polyclinique Du Parc - Hematologie	Caen	France	14052
12	Centre François Baclesse	Caen	France	14076
13	Centre Hospitalier - Service Hematologie	Chambery	France	73011
14	H.I.A. Percy Hematologie	Clamart	France	92141
15	Centre Hospitalier General - Medecine Interne	Dunkerque	France	59385
16	Hopital Albert Michallon - Hematologie	Grenoble	France	38043
17	CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A	La Roche Sur Yon	France	85025
18	Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale	La Rochelle	France	17019
19	Centre Hospitalier - Service de Médecine 7	Laval	France	53015
20	Clinique Victor Hugo	Le Mans	France	72015
21	CHRU CLAUDE HURIEZ - Maladies du sang	Lille	France	59037
22	Chu Edouard Herriot	Lyon	France	69437
23	INSTITUT PAOLI CALMETTE - Unité transplantation	Marseille	France	13272
24	CHR Hôp N.D. de Bon Secours - Service de Médecine A	Metz	France	57038
25	Hopital Jacques Monod - Rhumatologie	Montivilliers	France	76290
26	CHRU Hôtel Dieu, Service des Maladies du Sang	Nantes	France	44035
27	Centre Lacassagne	Nice	France	06050
28	Institut Curie - Service d'hématologie	Paris	France	75248
29	HOPITAL ST ANTOINE - Maladies du Sang	Paris	France	75571
30	Centre Hospitalier Général - Service d'Hématologie	Perpignan	France	66046
31	Hopital Du Haut Leveque - Hematologie	Pessac	France	33604
32	Centre Hospitalier de Lyon Sud	Pierre Benite	France	69945
33	CHRU Jean Bernard - Hématologie	Poitiers	France	86021
34	Centre Hospitalier Laennec - Service de Médecine A	Quimper	France	29107
35	Hôpital Robert Debré - Hématologie	Reims	France	51032
36	C.H.R. de Pontchaillou - Hématologie	Rennes	France	35033
37	CHRU Hôpital Sud - Médecine Interne	Rennes	France	35056
38	Centre Henri Becquerel - Service Hématologie	Rouen	France	76038
39	C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie	Saint Etienne	France	42055
40	Hôpital Nord - Hématologie	Saint Etienne	France	42055
41	CHU Hautepierre - Service Hématologie	Strasbourg	France	67000
42	HOPITAL HAUTEPIERRE - Service Rhumatologie	Strasbourg	France	67098
43	C.H.U. Rangueil - Service Rhumatologie	Toulouse	France	31054
44	C.H.U. PURPAN - Service Hématologie	Toulouse	France	31059
45	C.H.U. Bretonneau	Tours	France	37044
46	Centre Hospitalier - Service de Rhumatologie	Tulle	France	19012
47	Centre Hospitalier - Hématologie	Valence	France	26953
48	CHU Hôpital Brabois - Médecine interne-Hématologie	Vandoeuvre Les Nancy	France	54511
49	Centre Hospitalier Chubert - Médecine Interne	Vannes	France	56017