Collection of Additional Data Followed the Study IFM 2013-04
NCT ID: NCT03089411
Last Updated: 2017-03-27
Study Results
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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UNKNOWN
340 participants
OBSERVATIONAL
2017-03-20
2017-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
5. \- Female patients of child-bearing potential (FCBP):
* Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.
* Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
6. \- Male Patients:
* Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy
* Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy
7. \- All patients must:
* Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy
* Agree not to share study medication with another person.
8. \- Patients must be capable of giving informed consent
9. \- Patients must be affiliated with French social security system
Exclusion Criteria
2. \- Non-secretory Multiple myeloma
3. \- Proven AL-amyloidosis
4. \- Age ≥ 66 years old
5. \- Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
6. \- Radiation therapy in the 2 weeks preceding randomization
7. \- National Cancer Institute grade ≥ 2 peripheral neuropathy
8. \- Haemoglobin \< 8g/dL
9. \- Absolute neutrophil count \< 1,000 cells / µL, platelet count \< 50,000 cells / µL
10. \- Creatinine level \> 170 µmol/L or requiring dialysis.
11. \- Bilirubin, transaminases or GamaGT \> 3 UNL (upper normal limit)
12. \- Positive HIV serology, evidence of active Hepatitis B and C infection
13. \- Severe active infection
14. \- Inability to comply with an anti-thrombotic treatment regimen
15. \- A personal medical history of severe psychiatric disease
16. \- Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
17. \- Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
18. \- A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation \> or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
19. \- Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines
18 Years
66 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Centre Hospitalier de la région d'Annecy
Annecy, Pringy,, France
CHRU Hôpital Sud
Amiens, , France
CHU Angers
Angers, , France
Centre Hospitalier Argenteuil
Argenteuil, , France
Centre Hospitalier H.Duffaut
Avignon, , France
Centre Hospitalier de la Côte Basque
Bayonne, , France
CHRU de Besançon
Besançon, , France
Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Centre hospitalier Pierre Oudot
Bourgoin, , France
Hôpital A.Morvan
Brest, , France
CHU Caen Côte de Nacre
Caen, , France
CH René Dubos
Cergy-Pontoise, , France
Centre Hospitalier William Morey
Chalon/saone, , France
Hôpital d'instruction des armées Percy
Clamart, , France
CHU d'Estaing
Clermont-Ferrand, , France
Hôpitaux civils de Colmar
Colmar, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
CHU Henri Mondor
Créteil, , France
CHRU Dijon
Dijon, , France
Centre Hospitalier Général
Dunkirk, , France
CHRU - Hôpital A.Michallon
Grenoble, , France
Centre hospitalier départemental Vendée
La Roche-sur-Yon, , France
Hôpital Louis Pasteur
Le Coudray, , France
Centre Jean Bernard
Le Mans, , France
CH Le Mans
Le Mans, , France
Hopital Saint Vincent de Paul
Lille, , France
CHRU - Hôpital Claude Huriez
Lille, , France
CHU de Limoges
Limoges, , France
Hôpital Du Scorff
Lorient, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier de Meaux
Meaux, , France
CHR Metz Thionville
Metz, , France
Centre Hospitalier intercommunale Meulan les mureaux
Meulan-en-Yvelines, , France
Hopital E Muller
Mulhouse, , France
Nantes University Hospital
Nantes, , France
Hôpital de l'Archet 1
Nice, , France
Groupe Hospitalo-Universitaire Carémeau
Nîmes, , France
Institut CURIE
Paris, , France
Hôpital Cochin
Paris, , France
CHU - Hôpital St-Antoine
Paris, , France
Hôpital Pitié-Salpétrière
Paris, , France
AP-HP Hôpital Necker
Paris, , France
Hôpital Pitié-Salpétrière
Paris, , France
CH Saint Jean
Perpignan, , France
CHRU - Hôpital du Haut Lévêque
Pessac, , France
Centre Hospitalier de PERIGUEUX
Périgueux, , France
Centre Hospitalier Lyon sud
Pierre-Bénite, , France
CHRU - Hôpital Jean Bernard
Poitiers, , France
Hôpital R.Debré
Reims, , France
CHRU - Hôpital de Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Hospitalier Yves le Foll
Saint-Brieuc, , France
Centre René Huguenin
Saint-Cloud, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Centre Hospitalier
Saint-Quentin, , France
Centre hospitalier st Malo
St-Malo, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
CHRU - Hôpital Purpan
Toulouse, , France
CHRU - Hôpital Bretonneau
Tours, , France
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique Vannes et Auray
Vannes, , France
Countries
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Other Identifiers
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RC13_0284_03
Identifier Type: -
Identifier Source: org_study_id
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