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Myeloma MultipleNCT03089411

Collection of Additional Data Followed the Study IFM 2013-04

An observational study of Myeloma Multiple, run by Nantes University Hospital at 63 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Myeloma Multiple
How many people
340 participants
Where
63 sitesFrance
Study dates
20 Mar 2017to 15 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 340 patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient included in the study IFM 2013-04

Who may be able to join

None listed.

Who cannot join

  • - 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
Show all 19Show fewer
  • - 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
  • - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
  • - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
  • - 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)
  • - 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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

France63 sites

  • CHRU Hôpital Sud

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • Centre Hospitalier de la région d'Annecy

    Annecy, Pringy,, 74374

  • Centre Hospitalier Argenteuil

    Argenteuil, 95100

  • Centre Hospitalier H.Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • CHRU de Besançon

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33 300

  • Centre hospitalier Pierre Oudot

    Bourgoin, 38300

  • Hôpital A.Morvan

    Brest, 29609

  • CHU Caen Côte de Nacre

    Caen, 14033

  • CH René Dubos

    Cergy-Pontoise, 95303

  • Centre Hospitalier William Morey

    Chalon/saone, 71321

  • Hôpital d'instruction des armées Percy

    Clamart, 92141

  • CHU d'Estaing

    Clermont-Ferrand, 63000

  • Hôpitaux civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100

  • CHU Henri Mondor

    Créteil, 94 010

  • CHRU Dijon

    Dijon, 21000

  • Centre Hospitalier Général

    Dunkirk, 59 385

  • CHRU - Hôpital A.Michallon

    Grenoble, 38043

  • Centre hospitalier départemental Vendée

    La Roche-sur-Yon, 85925

  • Hôpital Louis Pasteur

    Le Coudray, 28000

  • Centre Jean Bernard

    Le Mans, 72000

  • CH Le Mans

    Le Mans, 72000

  • Hopital Saint Vincent de Paul

    Lille, 59020

  • CHRU - Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Hôpital Du Scorff

    Lorient, 56100

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • CHR Metz Thionville

    Metz, 57085

  • Centre Hospitalier intercommunale Meulan les mureaux

    Meulan-en-Yvelines, 78250

  • Hopital E Muller

    Mulhouse, 68100

  • Nantes University Hospital

    Nantes, 44093

  • Hôpital de l'Archet 1

    Nice, 06202

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes, 30029

  • Institut CURIE

    Paris, 75005

  • Hôpital Cochin

    Paris, 75014

  • CHU - Hôpital St-Antoine

    Paris, 75571

  • Hôpital Pitié-Salpétrière

    Paris, 75651

  • AP-HP Hôpital Necker

    Paris, 75743

  • Hôpital Pitié-Salpétrière

    Paris, 93009

  • Centre Hospitalier de PERIGUEUX

    Périgueux, 24000

  • CH Saint Jean

    Perpignan, 66046

  • CHRU - Hôpital du Haut Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon sud

    Pierre-Bénite, 69495

  • CHRU - Hôpital Jean Bernard

    Poitiers, 86021

  • Hôpital R.Debré

    Reims, 51092

  • CHRU - Hôpital de Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Hospitalier Yves le Foll

    Saint-Brieuc, 22 027

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42 271

  • Centre Hospitalier

    Saint-Quentin, 02 321

  • Centre hospitalier st Malo

    St-Malo, 35400

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 42271

  • CHRU - Hôpital Purpan

    Toulouse, 31059

  • CHRU - Hôpital Bretonneau

    Tours, 37044

  • CHRU - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH Bretagne Atlantique Vannes et Auray

    Vannes, 56017

Other trials in France

About this study

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"

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

Keywords
myeloma multiple, newly diagnosed
Medical subject headings
Multiple Myeloma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of death

    To evaluate Overall and Progression-Free Survival

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start20 Mar 2017
  3. Primary completion15 Jul 2017 (estimated)
  4. Study completion15 Jul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089411
Sponsor's protocol ID
RC13_0284_03
Status last verified
Mar 2017
First submitted
20 Mar 2017
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloma Multiple, run by Nantes University Hospital at 63 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of death (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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