Maintenance Therapy Using Lenalidomide in Myeloma

NCT ID: NCT00430365

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2018-09-30

Brief Summary

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Maintenance treatment of myeloma.

Detailed Description

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Conditions

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Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo group

Administration of oral placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral placebo

lenalidomide group

Administration of lenalidomide

Group Type EXPERIMENTAL

lenalidomide

Intervention Type DRUG

oral drug

Interventions

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lenalidomide

oral drug

Intervention Type DRUG

placebo

oral placebo

Intervention Type DRUG

Other Intervention Names

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REVLIMID

Eligibility Criteria

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Inclusion Criteria

* No signs of progression after transplant
* Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males)
* No active severe infection
* Satisfactory restoration of the haematological parameters defined by: PN \>1,000/mm3 and Platelets \> 75,000/mm3
* Bilirubin \< 35 umol/l and GOT/GPT/PAL\<3N
* Creatinine \< 160 umol/l.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Intergroupe Francophone du Myelome

NETWORK

Sponsor Role collaborator

Celgene

INDUSTRY

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ATTAL Michel, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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ZNA Middelheim

Antwerp, , Belgium

Site Status

Algemeen Centrumziekenhuis Antwerpen

Antwerp, , Belgium

Site Status

UZA Antwerpen

Antwerp, , Belgium

Site Status

Hôpital Saint Joseph

Arlon, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

UCL St Luc

Brussels, , Belgium

Site Status

Hôpital Saint Joseph

Gilly, , Belgium

Site Status

Hôpital Jolimont

Haine-Saint-Paul, , Belgium

Site Status

Heilig Hart Ziekenhuis

Roeselare, , Belgium

Site Status

UCL Mont-Godinne

Yvoir, , Belgium

Site Status

CH

Aix-en-Provence, , France

Site Status

CHRU

Amiens, , France

Site Status

CHRU Hôpital du Bocage

Angers, , France

Site Status

Centre hospitalier Argenteuil Victor Dupouy

Argenteuil, , France

Site Status

Centre hospitalier Duffaut

Avignon, , France

Site Status

Centre hospitalier de la côte basque

Bayonne, , France

Site Status

Hôpital Jean Minjoz

Besançon, , France

Site Status

CH

Blois, , France

Site Status

Hôpital Avicenne

Bobigny, , France

Site Status

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status

CHRU Hôpital haut Lévêque

Bordeaux, , France

Site Status

Hôpial Morvan

Brest, , France

Site Status

Polyclinique du Parc

Caen, , France

Site Status

Centre Baclesse

Caen, , France

Site Status

CH

Chartres, , France

Site Status

CH William Morey

Châlon-sur-Saône, , France

Site Status

Hôpital Antoine Béclère

Clamart, , France

Site Status

Hôpital d'instruction des Armées Percy

Clamart, , France

Site Status

CHRU Hôtel Dieu

Clermont-Ferrand, , France

Site Status

CH Louis Pasteur

Colmar, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

CHRU Dijon

Dijon, , France

Site Status

Centre hospitalier général

Dunkirk, , France

Site Status

CHRU Hôpital Michallon

Grenoble, , France

Site Status

Centre hospitalier départemental

La Roche-sur-Yon, , France

Site Status

CH

Le Mans, , France

Site Status

CHRU Hôpital Claude Huriez

Lille, , France

Site Status

Centre hospitalier Bodelio

Lorient, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

CHU Hôpital Edouard Herriot

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Hôpital Nord

Marseille, , France

Site Status

Hôpital Notre Dame de Bon Secours

Metz, , France

Site Status

CHRU Hôpitaux de Brabois

Nancy, , France

Site Status

CHRU Hôtel Dieu

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Hôpital Archet

Nice, , France

Site Status

Hôpital de l'Archet

Nice, , France

Site Status

Hôtel Dieu

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

CHU Hôpital St Antoine

Paris, , France

Site Status

Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

CHRU Hôpital Jean Bernard

Poitiers, , France

Site Status

Centre hospitalier de la région d'Annecy

Pringy, , France

Site Status

Hôpital Debré

Reims, , France

Site Status

CHRU Hôpital de Pontchaillou

Rennes, , France

Site Status

CHRU Hôpital Sud

Rennes, , France

Site Status

Centre hospitalier de Roanne

Roanne, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre hospitalier Yves Le Foll

Saint-Brieuc, , France

Site Status

Centre hospitalier de la Réunion

Saint-Denis, , France

Site Status

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

CHRU Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHU Toulouse Purpan

Toulouse, , France

Site Status

CHU Toulouse Rangueil

Toulouse, , France

Site Status

CHRU Hôpital Bretonneau

Tours, , France

Site Status

Centre hospitalier

Troyes, , France

Site Status

CH Chubert

Vannes, , France

Site Status

Center of Oncology/Hematology and transfusion Medicine, Kantonsspital

Aarau, , Switzerland

Site Status

Universitäts Spital

Basel, , Switzerland

Site Status

Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli

Bellinzona, , Switzerland

Site Status

Inselspital

Bern, , Switzerland

Site Status

Hôpital cantonal

Genêve, , Switzerland

Site Status

CHUV

Lausanne, , Switzerland

Site Status

Onkologie/Hämatologie Kantonsspital st Gallen

Sankt Gallen, , Switzerland

Site Status

Spital Thun-Simmental Onkologiezentrum

Thun, , Switzerland

Site Status

Institute of Oncology and Hematology Stadtspital Triemli

Zurich, , Switzerland

Site Status

Countries

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Belgium France Switzerland

References

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Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

Reference Type BACKGROUND
PMID: 9850028 (View on PubMed)

Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

Reference Type DERIVED
PMID: 22571202 (View on PubMed)

Other Identifiers

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French PHRC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0400401

Identifier Type: -

Identifier Source: org_study_id

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