Collection of Additional Data Followed the Study IFM 2013-04
1 other identifier
observational
340
1 country
63
Brief Summary
Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Shorter than P25 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2017
CompletedMarch 27, 2017
March 1, 2017
4 months
March 20, 2017
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of death
To evaluate Overall and Progression-Free Survival
6 months
Eligibility Criteria
340 patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient included in the study IFM 2013-04
You may not qualify if:
- \- Asymptomatic Multiple myeloma
- \- Non-secretory Multiple myeloma
- \- Proven AL-amyloidosis
- \- Age ≥ 66 years old
- \- 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)
- \- Radiation therapy in the 2 weeks preceding randomization
- \- National Cancer Institute grade ≥ 2 peripheral neuropathy
- \- Haemoglobin \< 8g/dL
- \- Absolute neutrophil count \< 1,000 cells / µL, platelet count \< 50,000 cells / µL
- \- Creatinine level \> 170 µmol/L or requiring dialysis.
- \- Bilirubin, transaminases or GamaGT \> 3 UNL (upper normal limit)
- \- Positive HIV serology, evidence of active Hepatitis B and C infection
- \- Severe active infection
- \- Inability to comply with an anti-thrombotic treatment regimen
- \- A personal medical history of severe psychiatric disease
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Centre Hospitalier de la région d'Annecy
Annecy, Pringy,, 74374, France
CHRU Hôpital Sud
Amiens, 80054, France
CHU Angers
Angers, 49033, France
Centre Hospitalier Argenteuil
Argenteuil, 95100, France
Centre Hospitalier H.Duffaut
Avignon, 84902, France
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
CHRU de Besançon
Besançon, 25030, France
Hôpital Avicenne
Bobigny, 93009, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33 300, France
Centre hospitalier Pierre Oudot
Bourgoin, 38300, France
Hôpital A.Morvan
Brest, 29609, France
CHU Caen Côte de Nacre
Caen, 14033, France
CH René Dubos
Cergy-Pontoise, 95303, France
Centre Hospitalier William Morey
Chalon/saone, 71321, France
Hôpital d'instruction des armées Percy
Clamart, 92141, France
CHU d'Estaing
Clermont-Ferrand, 63000, France
Hôpitaux civils de Colmar
Colmar, 68024, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100, France
CHU Henri Mondor
Créteil, 94 010, France
CHRU Dijon
Dijon, 21000, France
Centre Hospitalier Général
Dunkirk, 59 385, France
CHRU - Hôpital A.Michallon
Grenoble, 38043, France
Centre hospitalier départemental Vendée
La Roche-sur-Yon, 85925, France
Hôpital Louis Pasteur
Le Coudray, 28000, France
Centre Jean Bernard
Le Mans, 72000, France
CH Le Mans
Le Mans, 72000, France
Hopital Saint Vincent de Paul
Lille, 59020, France
CHRU - Hôpital Claude Huriez
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Hôpital Du Scorff
Lorient, 56100, France
Centre Léon Bérard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Hospitalier de Meaux
Meaux, 77104, France
CHR Metz Thionville
Metz, 57085, France
Centre Hospitalier intercommunale Meulan les mureaux
Meulan-en-Yvelines, 78250, France
Hopital E Muller
Mulhouse, 68100, France
Nantes University Hospital
Nantes, 44093, France
Hôpital de l'Archet 1
Nice, 06202, France
Groupe Hospitalo-Universitaire Carémeau
Nîmes, 30029, France
Institut CURIE
Paris, 75005, France
Hôpital Cochin
Paris, 75014, France
CHU - Hôpital St-Antoine
Paris, 75571, France
Hôpital Pitié-Salpétrière
Paris, 75651, France
AP-HP Hôpital Necker
Paris, 75743, France
Hôpital Pitié-Salpétrière
Paris, 93009, France
CH Saint Jean
Perpignan, 66046, France
CHRU - Hôpital du Haut Lévêque
Pessac, 33604, France
Centre Hospitalier de PERIGUEUX
Périgueux, 24000, France
Centre Hospitalier Lyon sud
Pierre-Bénite, 69495, France
CHRU - Hôpital Jean Bernard
Poitiers, 86021, France
Hôpital R.Debré
Reims, 51092, France
CHRU - Hôpital de Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier Yves le Foll
Saint-Brieuc, 22 027, France
Centre René Huguenin
Saint-Cloud, 92210, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42 271, France
Centre Hospitalier
Saint-Quentin, 02 321, France
Centre hospitalier st Malo
St-Malo, 35400, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 42271, France
CHRU - Hôpital Purpan
Toulouse, 31059, France
CHRU - Hôpital Bretonneau
Tours, 37044, France
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
CH Bretagne Atlantique Vannes et Auray
Vannes, 56017, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2017
First Posted
March 24, 2017
Study Start
March 20, 2017
Primary Completion
July 15, 2017
Study Completion
July 15, 2017
Last Updated
March 27, 2017
Record last verified: 2017-03