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

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

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

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

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 Jallieu, France

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