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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03089411
Other study ID # RC13_0284_03
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 20, 2017
Last updated March 23, 2017
Start date March 20, 2017
Est. completion date July 15, 2017

Study information

Verified date March 2017
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 340
Est. completion date July 15, 2017
Est. primary completion date July 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 66 Years
Eligibility Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient

1. - 18 = age < 66 years

2. - Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2

3. - Patients must be eligible for Autologous Stem Cell Transplantation

4. - Patients must have measurable disease by serum M-protein = 10 g/L and/or urine M-protein =200mg/day

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:

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


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU Hôpital Sud Amiens
France CHU Angers Angers
France Centre Hospitalier de la région d'Annecy Annecy Pringy,
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 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 Creteil
France CHRU Dijon Dijon
France Centre Hospitalier Général Dunkerque,
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 CHRU - Hôpital Claude Huriez Lille
France Hopital Saint Vincent de Paul 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
France Hopital E Muller Mulhouse
France Nantes University Hospital Nantes
France Hôpital de l'Archet 1 Nice
France Groupe Hospitalo-Universitaire Carémeau Nimes
France AP-HP Hôpital Necker Paris
France Hôpital Cochin Paris
France Hôpital Pitié-Salpétrière Paris
France Hôpital Pitié-Salpétrière Paris
France Institut CURIE Paris
France CHU - Hôpital St-Antoine PARIS cedex 12
France Centre Hospitalier de PERIGUEUX Perigueux
France CH Saint Jean Perpignan
France CHRU - Hôpital du Haut Lévêque Pessac
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 st Malo Saint Malo
France Centre Hospitalier Saint Quentin
France Centre Hospitalier Yves le Foll St Brieuc
France Centre René Huguenin St Cloud
France Institut de Cancérologie de la Loire St Priest-en-jarez
France Hôpitaux Universitaires de Strasbourg Strasbourg
France CHRU - Hôpital Purpan Toulouse
France CHRU - Hôpital Bretonneau Tours
France CHRU - Hôpitaux de Brabois Vandoeuvre Les Nancy
France CH Bretagne Atlantique Vannes et Auray Vannes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of death To evaluate Overall and Progression-Free Survival 6 months
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