An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice

NCT ID: NCT02902900

Last Updated: 2022-06-27

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

Total Enrollment

2504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2022-05-31

Brief Summary

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This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Imnovid

Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patient (age ≥ 18 yrs),
* Diagnosed with multiple myeloma (measurable or not),
* In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2019,
* Patient already included in the Imnovid registry,
* Having received oral and written information about the study, and having given their consent to participate.

Exclusion Criteria

* Previous participation in a clinical trial with pomalidomide,
* Treatment with pomalidomide in a previous line,
* Simultaneous participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Centre Hospitalier General

Albi, , France

Site Status

Groupe Hospitalier Sud

Amiens, , France

Site Status

Hotel Dieu

Angers, , France

Site Status

Ch D'Arras

Arras, , France

Site Status

Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

Centre Hospitalier H. Duffaut

Avignon, , France

Site Status

Centre Hospitalier Jeanne d'Arc

Bar-le-Duc, , France

Site Status

Chic Cote Basque Bayonne

Bayonne, , France

Site Status

Hopital Nord Franche-Comte - Site de Belfort

Belfort, , France

Site Status

Hopital Jean Minjoz

Besançon, , France

Site Status

Centre Hospitalier General

Blois, , France

Site Status

Hôpital Avicenne

Bobigny, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Polyclin Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status

Ch Docteur Duchenne

Boulogne-sur-Mer, , France

Site Status

Ch de Fleyriat

Bourg-en-Bresse, , France

Site Status

Ch Pierre Oudot

Bourgoin, , France

Site Status

Hopital Augustin Morvan

Brest, , France

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Hôpital d'Instruction des Armées

Brest Armees Cedex 9, , France

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Ch de Brive La Gaillarde

Brive-la-Gaillarde, , France

Site Status

Hopital Cote de Nacre

Caen, , France

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Hopital Pierre Nouveau

Cannes, , France

Site Status

Clinique Du Parc

Castelnau-le-Lez, , France

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Hopital Prive Sevigne

Cesson-Sévigné, , France

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Médipôle de Savoie

Challes-les-Eaux, , France

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Ch William Morey

Chalon-sur-Saône, , France

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Ch de Chambery

Chambéry, , France

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Centre Hospitalier

Cholet, , France

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Hopital Antoine Beclere

Clamart, , France

Site Status

Chu Estaing

Clermont-Ferrand, , France

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Pole Sante Republique

Clermont-Ferrand, , France

Site Status

Ch Sud Francilien

Corbeil-Essonnes, , France

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Centre Hospitalier de Creil

Creil, , France

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Gh Henri Mondor Albert Chenevier

Créteil, , France

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Ch de Dax

Dax, , France

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Hopital Francois Mitterrand

Dijon, , France

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Ch Dracenie

Draguignan, , France

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Ch de Dunkerque

Dunkirk, , France

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Centre Hospitalier Emile Durkheim

Épinal, , France

Site Status

Clinique Pasteur

Évreux, , France

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Chi de Frejus Saint Raphael

Fréjus, , France

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Chi Des Alpes Du Sud

Gap, , France

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Institut Daniel Hollard

Grenoble, , France

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Hopital Charles Foix

Ivry-sur-Seine, , France

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Polyclinique de Blois

La Chaussée-Saint-Victor, , France

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Ch Dptal Les Oudairies

La Roche-sur-Yon, , France

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Centre Hospitalier de La Rochelle

La Rochelle, , France

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Hopital Albert Michallon

La Tronche, , France

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Ch Andre Mignot

Le Chesnay, , France

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Hopital Louis Pasteur

Le Coudray, , France

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Clinique Victor Hugo

Le Mans, , France

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Ch Du Mans

Le Mans, , France

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Ch Du Docteur Schaffner

Lens, , France

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Hopital Robert Boulin

Libourne, , France

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Hopital Saint Vincent

Lille, , France

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Hopital Claude Huriez

Lille, , France

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Hopital Dupuytren

Limoges, , France

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Ch Bretagne Sud Site Lorient

Lorient, , France

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Centre Hospitalier General

Lourdes, , France

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Hopital Edouard Herriot

Lyon, , France

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Institut J Paoli-Calmettes

Marseille, , France

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Hôpital Saint Joseph

Marseille, , France

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Hopital de La Conception

Marseille, , France

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Centre Hospitalier de Martigues

Martigues, , France

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Ch de Meaux

Meaux, , France

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Hopital Marc Jacquet

Melun, , France

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Hopital Belle Isle

Metz, , France

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HOPITAL Metz Mercy

Metz, , France

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Hopital Jacques Monod

Montivilliers, , France

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Clinique Beau Soleil

Montpellier, , France

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Hopital Saint Eloi

Montpellier, , France

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Ch Des Pays de Morlaix

Morlaix, , France

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Ch Mulhouse

Mulhouse, , France

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Hopital Hotel Dieu Et Hme

Nantes, , France

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Centre Catherine de Sienne

Nantes, , France

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Ch Pierre Beregovoy

Nevers, , France

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Centre Antoine Lacassagne

Nice, , France

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Hopital de L'Archet

Nice, , France

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Hopital Caremeau

Nîmes, , France

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Hopital Saint Louis

Paris, , France

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Hôpital Saint Antoine

Paris, , France

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Gh Pitie Salpetriere

Paris, , France

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Gh Cochin St Vincent de Paul

Paris, , France

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Hopital Necker Enfants Malades

Paris, , France

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Hopital Saint Jean

Perpignan, , France

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Polyclinique Francheville

Périgueux, , France

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Ch de Perigueux

Périgueux, , France

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Ch Lyon Sud

Pierre-Bénite, , France

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Hopital La Miletrie

Poitiers, , France

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Ch Rene Dubos

Pontoise, , France

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CH Annecy Genevois

Pringy, , France

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Chi de Cornouaille

Quimper, , France

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Ch de Rambouillet

Rambouillet, , France

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Chu Reims

Reims, , France

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Hopital Robert Debre

Reims, , France

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Hopital Pontchaillou

Rennes, , France

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Chu Rennes - Hopital Sud

Rennes, , France

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Ch de Roanne

Roanne, , France

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Hopitaux Drome Nord

Romans-sur-Isère, , France

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Hopital Victor Provo

Roubaix, , France

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Centre Henri Becquerel

Rouen, , France

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Hopital Yves Le Foll

Saint-Brieuc, , France

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Centre Rene Huguenin

Saint-Cloud, , France

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Centre Hospitalier General

Saint-Germain-en-Laye, , France

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Centre Rene Gauducheau

Saint-Herblain, , France

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Hôpital Nord

Saint-Priest-en-Jarez, , France

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Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

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Chg de Saint Quentin

Saint-Quentin, , France

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C.H. Jacques Boutard

Saint-Yrieix-la-Perche, , France

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Centre Hospitalier

Sens, , France

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Centre Hospitalier

St-Malo, , France

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Hopital Hautepierre

Strasbourg, , France

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Hopital Hautepierre

Strasbourg, , France

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Hopital Foch

Suresnes, , France

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C.H.I Les Hopitaux Du Leman

Thonon-les-Bains, , France

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Hopital Sainte Musse

Toulon, , France

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Hopital Rangueil

Toulouse, , France

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IUCT Oncopole

Toulouse, , France

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Hopital Bretonneau

Tours, , France

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Hopital Des Hauts Clos

Troyes, , France

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Centre Hospitalier de Valence

Valence, , France

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Ch de Valenciennes

Valenciennes, , France

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Hopitaux de Brabois

Vandœuvre-lès-Nancy, , France

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Ch Bretagne Atlantique de Vannes

Vannes, , France

Site Status

Chi de La Haute Saone de Vesoul

Vesoul, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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Waldschmidt JM, Simon A, Wider D, Muller SJ, Follo M, Ihorst G, Decker S, Lorenz J, Chatterjee M, Azab AK, Duyster J, Wasch R, Engelhardt M. CXCL12 and CXCR7 are relevant targets to reverse cell adhesion-mediated drug resistance in multiple myeloma. Br J Haematol. 2017 Oct;179(1):36-49. doi: 10.1111/bjh.14807. Epub 2017 Jul 2.

Reference Type BACKGROUND
PMID: 28670693 (View on PubMed)

Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

Reference Type BACKGROUND
PMID: 29802551 (View on PubMed)

Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

Reference Type BACKGROUND
PMID: 30282798 (View on PubMed)

Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

Reference Type BACKGROUND
PMID: 30792190 (View on PubMed)

Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

Reference Type BACKGROUND
PMID: 30773308 (View on PubMed)

Li Y, Wang X, Liu L, Zhang C, Gomez D, Reyes J, Palmisano M, Zhou S. An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Apr;8(3):346-354. doi: 10.1002/cpdd.470. Epub 2018 May 10.

Reference Type BACKGROUND
PMID: 29746728 (View on PubMed)

Related Links

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Other Identifiers

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CC-4047-MM-018

Identifier Type: -

Identifier Source: org_study_id

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