Collection of Additional Data Followed the Study IFM 2013-04

• Conditions: Myeloma Multiple

• Registration Number: NCT03089411
• Lead Sponsor: Nantes University Hospital

Brief Summary

Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-20
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-24
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

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Exclusion Criteria

1. • Asymptomatic Multiple myeloma
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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of death	6 months	To evaluate Overall and Progression-Free Survival

Trial Locations

Locations (62)

Centre Hospitalier de la région d'Annecy; 🇫🇷 Annecy, Pringy,, France

Centre Hospitalier Général; 🇫🇷 Dunkerque,, France

Centre hospitalier départemental Vendée; 🇫🇷 La Roche Sur Yon, France

Centre Jean Bernard; 🇫🇷 Le Mans, France

Centre Hospitalier H.Duffaut; 🇫🇷 Avignon, France

Hôpital d'instruction des armées Percy; 🇫🇷 Clamart, France

CHU d'Estaing; 🇫🇷 Clermont Ferrand, France

Hôpitaux civils de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier Yves le Foll; 🇫🇷 St Brieuc, France

Hôpital Cochin; 🇫🇷 Paris, France

CH Saint Jean; 🇫🇷 Perpignan, France

CHU Caen Côte de Nacre; 🇫🇷 Caen, France

Hôpital Louis Pasteur; 🇫🇷 Le Coudray, France

CHRU - Hôpital Bretonneau; 🇫🇷 Tours, France

Hôpital de l'Archet 1; 🇫🇷 Nice, France

Centre Hospitalier intercommunale Meulan les mureaux; 🇫🇷 Meulan, France

CHU - Hôpital St-Antoine; 🇫🇷 PARIS cedex 12, France

Centre Hospitalier Lyon sud; 🇫🇷 Pierre bénite, France

CHRU Hôpital Sud; 🇫🇷 Amiens, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Centre hospitalier Pierre Oudot; 🇫🇷 Bourgoin Jallieu, France

CH René Dubos; 🇫🇷 Cergy-pontoise, France

CHRU - Hôpital Claude Huriez; 🇫🇷 Lille, France

Hôpital Du Scorff; 🇫🇷 Lorient, France

Centre Hospitalier de Meaux; 🇫🇷 Meaux, France

CHU Henri Mondor; 🇫🇷 Creteil, France

CHRU - Hôpital du Haut Lévêque; 🇫🇷 Pessac, France

Centre Hospitalier de PERIGUEUX; 🇫🇷 Perigueux, France

Hôpital R.Debré; 🇫🇷 Reims, France

CHRU - Hôpital A.Michallon; 🇫🇷 Grenoble, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes, France

CH Le Mans; 🇫🇷 Le Mans, France

Hopital Saint Vincent de Paul; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CHU de Limoges; 🇫🇷 Limoges, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHR Metz Thionville; 🇫🇷 Metz, France

Nantes University Hospital; 🇫🇷 Nantes, France

Institut CURIE; 🇫🇷 Paris, France

Hôpital Pitié-Salpétrière; 🇫🇷 Paris, France

AP-HP Hôpital Necker; 🇫🇷 Paris, France

CHRU - Hôpital Jean Bernard; 🇫🇷 Poitiers, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHRU - Hôpital Purpan; 🇫🇷 Toulouse, France

Centre hospitalier st Malo; 🇫🇷 Saint Malo, France

Centre Hospitalier; 🇫🇷 Saint Quentin, France

Centre René Huguenin; 🇫🇷 St Cloud, France

Institut de Cancérologie de la Loire; 🇫🇷 St Priest-en-jarez, France

CHRU - Hôpitaux de Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

CH Bretagne Atlantique Vannes et Auray; 🇫🇷 Vannes, France

CHRU de Besançon; 🇫🇷 Besançon, France

CHU Angers; 🇫🇷 Angers, France

Centre Hospitalier Argenteuil; 🇫🇷 Argenteuil, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

Centre Hospitalier William Morey; 🇫🇷 Chalon/saone, France

CHRU Dijon; 🇫🇷 Dijon, France

Hopital E Muller; 🇫🇷 Mulhouse, France

Groupe Hospitalo-Universitaire Carémeau; 🇫🇷 Nimes, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Hôpital A.Morvan; 🇫🇷 Brest, France

CHRU - Hôpital de Pontchaillou; 🇫🇷 Rennes, France