A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Last updated: March 26, 2025
Sponsor: Intergroupe Francophone du Myelome
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Bone Neoplasm

Cancer

Treatment

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)

Daratumumab

Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab

Clinical Study ID

NCT02541383
IFM 2015-01
2014-004781-15
54767414MMY3006
HO131
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of previously untreated multiple myeloma (MM)

  • Have a confirmed diagnosis and eligible for high dose chemotherapy and autologousstem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG)performance status score of 0,1 or 2

Exclusion

Exclusion Criteria:

  • previous treatment for Multiple Myeloma

  • Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma

  • Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation)for any plasma cell dyscrasia, with the exception of an emergency use of a shortcourse (equivalent of dexamethasone 40 mg/day for a maximum 4 days) ofcorticosteroids before treatment, or received an investigational drug or used aninvasive investigational medical device within 4 weeks before Cycle 1, Day 1

  • history of malignancy (other than Multiple Myeloma) within 10 years before the dateof randomization, except for the following if treated and not active: basal cell ornonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ,ductal carcinoma in situ of breast, or International Federation of Gynecology andObstetrics (FIGO) Stage 1 carcinoma of the cervix

  • known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma

  • any concurrent medical or psychiatric condition or disease (eg, autoimmune disease,active systemic disease, myelodysplasia) that is likely to interfere with the studyprocedures or results, or that in the opinion of the investigator, would constitutea hazard for participating in this study

Study Design

Total Participants: 1085
Treatment Group(s): 3
Primary Treatment: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Phase: 3
Study Start date:
September 01, 2015
Estimated Completion Date:
September 01, 2023

Study Description

This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.

Connect with a study center

  • BE-Antwerp-ZNA Stuivenberg

    Antwerp,
    Belgium

    Site Not Available

  • AZ St Jan Brugge Oostende AV

    Brugge,
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Bruxelles,
    Belgium

    Site Not Available

  • UCL Saint-Luc

    Bruxelles,
    Belgium

    Site Not Available

  • UZ Brussel

    Bruxelles,
    Belgium

    Site Not Available

  • GHDC

    Charleroi,
    Belgium

    Site Not Available

  • UZ Gent

    Gent,
    Belgium

    Site Not Available

  • CH Jolimont

    La Louviere,
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven,
    Belgium

    Site Not Available

  • Domaine Universitaire du Sart Tilman

    Liege,
    Belgium

    Site Not Available

  • CHU Vésale

    Montigny Le Tilleul,
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare,
    Belgium

    Site Not Available

  • AZ Turnhout

    Turnhout,
    Belgium

    Site Not Available

  • UCL Mont-Godinne

    Yvoir,
    Belgium

    Site Not Available

  • CHU Amiens Sud

    AMIENS Cedex 1,
    France

    Site Not Available

  • CHRU-Hôpital du Bocage

    ANGERS Cedex 1,
    France

    Site Not Available

  • Centre Hospitalier H.Duffaut

    AVIGNON Cedex 9,
    France

    Site Not Available

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    Argenteuil,
    France

    Site Not Available

  • Hôpital Jean Minjoz

    BESANCON Cedex,
    France

    Site Not Available

  • Hôpital Avicenne

    BOBIGNY Cedex,
    France

    Site Not Available

  • Hôpital de Fleyriat

    BOURG EN BRESSE Cedex,
    France

    Site Not Available

  • CHRU Brest - Hôpital A. Morvan

    BREST Cedex,
    France

    Site Not Available

  • Centre hospitalier de la Côte Basque

    Bayonne,
    France

    Site Not Available

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux,
    France

    Site Not Available

  • CHU Caen - Côte de Nacre

    CAEN Cedex,
    France

    Site Not Available

  • Hôpital d'Instruction des Armées Percy

    CLAMART Cedex,
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    CORBEIL-ESSONNES Cedex,
    France

    Site Not Available

  • Clinique du Parc

    Castelnau-le-lez,
    France

    Site Not Available

  • CH René Dubos

    Cergy-pontoise,
    France

    Site Not Available

  • Hôpital Privé Sévigné

    Cesson-Sévigné,
    France

    Site Not Available

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100
    France

    Site Not Available

  • Centre Hospitalier William Morey

    Chalons Sur Saone,
    France

    Site Not Available

  • CH Chambéry

    Chambery,
    France

    Site Not Available

  • CHU d'Estaing

    Clermont-ferrand,
    France

    Site Not Available

  • CHU Henri Mondor

    Creteil,
    France

    Site Not Available

  • CHRU Dijon - Hôpital des Enfants

    Dijon,
    France

    Site Not Available

  • Centre Hospitalier Général

    Dunkerque,
    France

    Site Not Available

  • CHRU Hôpital A. Michallon

    GRENOBLE Cedex 9,
    France

    Site Not Available

  • CHD Vendée

    LA ROCHE SUR YON Cedex 9,
    France

    Site Not Available

  • Centre Hospitalier

    LE MANS Cedex,
    France

    Site Not Available

  • CHRU Hôpital Claude Huriez

    LILLE Cedex,
    France

    Site Not Available

  • CHV André Mignot - Université de Versailles

    Le Chesnay,
    France

    Site Not Available

  • CH de Chartres - Hôpital Louis Pasteur

    Le Coudray,
    France

    Site Not Available

  • Clinique Victor Hugo

    Le Mans,
    France

    Site Not Available

  • GH de l'Institut Catholique Saint Vincent

    Lille,
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Limoges

    Limoges,
    France

    Site Not Available

  • Hôpital du Scorff

    Lorient,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Institut Paoli Calmettes

    MARSEILLE Cedex,
    France

    Site Not Available

  • Hôpital de Mercy (CHR Metz-Thionville)

    METZ Cedex 1,
    France

    Site Not Available

  • Hopital Saint Eloi - CHU Montpellier

    MONTPELLIER Cedex,
    France

    Site Not Available

  • CH Meaux

    Meaux,
    France

    Site Not Available

  • Hôpital E. Muller

    Mulhouse,
    France

    Site Not Available

  • Clinique de l'Archet

    NICE Cedex 3,
    France

    Site Not Available

  • CHU Carémeau

    NIMES Cedex 9,
    France

    Site Not Available

  • Centre Catherine de Sienne

    Nantes, 44202
    France

    Site Not Available

  • CHRU Hôtel Dieu

    Nantes Cedex 1,
    France

    Site Not Available

  • CH La Source

    Orleans Cedex 2,
    France

    Site Not Available

  • Hôpital Saint Louis

    PARIS Cedex 10,
    France

    Site Not Available

  • CHU Hôpital Saint Antoine

    PARIS Cedex 12,
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    PIERRE-BENITE Cedex,
    France

    Site Not Available

  • Ch Annecy Genevois

    PRINGY Cedex,
    France

    Site Not Available

  • Hôpital Cochin

    Paris,
    France

    Site Not Available

  • Hôpital Necker

    Paris,
    France

    Site Not Available

  • Institut Curie

    Paris,
    France

    Site Not Available

  • La Pitié

    Paris,
    France

    Site Not Available

  • Centre Hospitalier de Perigueux

    Perigueux,
    France

    Site Not Available

  • CH Saint Jean

    Perpignan,
    France

    Site Not Available

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie

    Pessac,
    France

    Site Not Available

  • CHU Poitiers - Pôle régional de Cancérologie

    Poitiers,
    France

    Site Not Available

  • Hôpital Robert Debré

    REIMS Cedex,
    France

    Site Not Available

  • CHRU Hôpital de Pontchaillou

    RENNES Cedex 9,
    France

    Site Not Available

  • Centre Henri Becquerel

    ROUEN Cedex 1,
    France

    Site Not Available

  • Centre Hospitalier

    SAINT QUENTIN Cedex,
    France

    Site Not Available

  • Institut de Cancérologie Lucien Neuwirth

    Saint Priest-en-jarez,
    France

    Site Not Available

  • Centre Hospitalier Yves Le Foll

    Saint-brieuc,
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Strasbourg Oncologie Médicale

    Strasbourg,
    France

    Site Not Available

  • Pôle IUCT Oncopole CHU

    TOULOUSE Cedex 9,
    France

    Site Not Available

  • CHRU Hôpital Bretonneau

    TOURS Cedex,
    France

    Site Not Available

  • CHRU Hôpitaux de Brabois

    VANDOEUVRE LES NANCY Cedex,
    France

    Site Not Available

  • CHBA

    VANNES Cedex,
    France

    Site Not Available

  • UH Luxembourg

    Luxembourg,
    Luxembourg

    Site Not Available

  • MC Alkmaar

    Alkmaar,
    Netherlands

    Site Not Available

  • Meander MC

    Amersfoort,
    Netherlands

    Site Not Available

  • AMC

    Amsterdam,
    Netherlands

    Site Not Available

  • OLVG

    Amsterdam,
    Netherlands

    Site Not Available

  • Vumc

    Amsterdam,
    Netherlands

    Site Not Available

  • Ziekenhuis Rijnstate

    Arnhem,
    Netherlands

    Site Not Available

  • Amphia Hospital Breda

    Breda,
    Netherlands

    Site Not Available

  • RdGG

    Delft,
    Netherlands

    Site Not Available

  • Haga zkh

    Den Haag, 2545 CH
    Netherlands

    Site Not Available

  • Deventer zkh

    Deventer,
    Netherlands

    Site Not Available

  • Albert Schweitzer zkh

    Dordrecht,
    Netherlands

    Site Not Available

  • Maxima MC

    Eindhoven,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

  • UMCG

    Groningen,
    Netherlands

    Site Not Available

  • Atrium MC/Zuyderland MC

    Heerlen,
    Netherlands

    Site Not Available

  • Tergooiziekenhuizen, location Hilversum

    Hilversum, 1201 DA
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp,
    Netherlands

    Site Not Available

  • MC Leeuwarden

    Leeuwarden,
    Netherlands

    Site Not Available

  • LUMC

    Leiden,
    Netherlands

    Site Not Available

  • MUMC

    Maastricht,
    Netherlands

    Site Not Available

  • Antonius zkh

    Nieuwegein,
    Netherlands

    Site Not Available

  • Radboudumc

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Site Not Available

  • Elisabeth zkh

    Tilburg,
    Netherlands

    Site Not Available

  • UMCU

    Utrecht,
    Netherlands

    Site Not Available

  • Isala Klinieken

    Zwolle,
    Netherlands

    Site Not Available

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