Collection of Additional Data Followed the Study IFM 2013-04

Myeloma Multiple Clinical Trial

Official title:

Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03089411
• Other study ID #: RC13_0284_03
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

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