Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma (HO95)

August 17, 2023 updated by: Stichting Hemato-Oncologie voor Volwassenen Nederland

A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

Study phase: phase III

Study objective:

  • Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT)
  • Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation
  • Comparison of single versus tandem high dose Melphalan with ASCT

Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive

Study design: Prospective, multicenter, intergroup, randomized

Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1503

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • AU-Brisbane-PAH
      • Canberra, Australia
        • AU-Canberra-CANBERRAHOSPITAL
      • Melbourne, Australia
        • AU-Melbourne-ALFRED
      • Sydney, Australia
        • Prince of Wales Hospital
      • Sydney, Australia
        • St George Hospital
      • Sydney, Australia
        • AU-Sydney-CONCORD
      • Sydney, Australia
        • AU-Sydney-NEPEAN
  • Austria
      • Linz, Austria
        • Krankenhaus d.Elisabethinen
      • Salzburg, Austria
        • Landeskrankenhaus Salzburg
      • Vienna, Austria
        • AT-Vienna-HANUSCH
  • Belgium
      • Antwerpen, Belgium
        • BE-Antwerpen-ZNASTUIVENBERG
      • Antwerpen, Belgium
        • BE-Antwerpen Edegem-UZA
      • Haine-Saint-Paul, Belgium
        • BE-Haine-Saint-Paul-JOLIMONT
      • La Louvière, Belgium
        • Chu Tivoli
      • Liège, Belgium
        • BE-Liege-CHRCITADELLE
      • Mons, Belgium
        • BE-Mons-AMBROISE
      • Mons, Belgium
        • CHR Saint Joseph
      • Roeselare, Belgium
        • BE-Roeselare-AZDELTA
      • Saint-Ghislain, Belgium
        • RHMS
      • Tournai, Belgium
        • CH WAPI
      • Turnhout, Belgium
        • AZ Turnhout
  • Czechia
      • Brno, Czechia
        • CZ-Brno-UHBRNO
      • Hradec, Czechia
        • Kralove-University Hospital Hradec Kralove
      • Olomouc, Czechia
        • CZ-Olomouc-FNOL
      • Ostrava, Czechia
        • CZ-Ostrava-Poruba-FNO
      • Plzen, Czechia
        • University Hospital Plzen
      • Prague, Czechia
        • University Hospital Kralovske Vinohrady
  • Denmark
      • Aalborg, Denmark
        • DK-Aalborg-AALBORGUH
      • Aarhus, Denmark
        • DK-Aarhus N-AUH
      • Copenhagen, Denmark
        • DK-Copenhagen-RIGSHOSPITALET
      • Herlev, Denmark
        • DK-Herlev-HERLEV
      • Odense, Denmark
        • DK-Odense-OUH
      • Roskilde, Denmark
        • DK-Roskilde-ROSKILDE
  • Finland
      • Turku, Finland
        • FI-Turku-TYKS
  • Greece
      • Athens, Greece
        • GR-Athens-ALEXANDRA
  • Hungary
      • Budapest, Hungary
        • St. Istvan and St. Laszlo Korhaz Hospital
      • Szeged, Hungary
        • Szeged University Hospital
  • Italy
      • Alessandria, Italy
        • SS Antonio e Biogio
      • Ancona, Italy
        • AOU Umberto I-Clinica di Ematologica
      • Ascoli Piceno, Italy
        • Ospedale C. e G. Mazzoni-Ematologia
      • Avellino, Italy
        • A.O.R.N. San G. Moscati
      • Bari, Italy
        • Policlinico di Bari
      • Bergamo, Italy
        • Oaspedali Riuniti_Div di Ematologia
      • Bologna, Italy
        • Instituto di Ematologia e Oncologia Medica
      • Bolzano, Italy
        • Ospedale Generale Regionale_Div di Ema e Centro
      • Brescia, Italy
        • Spedali Civili_U.O.Ematologia
      • Brindisi, Italy
        • Pres Osp Di Summa
      • Cagliari, Italy
        • Presidio Osp R. Binaghi
      • Candiolo, Italy
        • Inst per la Ricerca e la Cura del Cancro Di
      • Catania, Italy
        • Ospedale Ferrarotto-Ema
      • Cosenza, Italy
        • Presidio ospedaliero dell'annunziata
      • Cuneo, Italy
        • OspedaleCivico S Croce e carle
      • Foggia, Italy
        • Ospedali riuniti di Foggia
      • Gallarate, Italy
        • Azienda Ospedaliera San Antonio Abate
      • Genova, Italy
        • Azienda Ospedaliera Universitaria S. Martino_Clinica Ematologica
      • Genova, Italy
        • Azienda Ospedaliera Universitaria S. Martino_Ematologia 1
      • Genova, Italy
        • Azienda Ospedaliera Universitaria S. Martino_Ematologia 2
      • Latina, Italy
        • Università La Sapienza Polo Pontino
      • Lecco, Italy
        • Ospedale A. Manzoni
      • Marche, Italy
        • ASUR Regione Marche
      • Meldola, Italy
        • IRST
      • Messina, Italy
        • Azienda Ospedaliera Papardo
      • Messina, Italy
        • Policlinico Gaetano Martino
      • Mestre, Italy
        • Osp Dell Angelo
      • Milano, Italy
        • Ospedale Niguarda Cà Grande
      • Milano, Italy
        • Istituto Nazionale dei Tumori-Ema
      • Modena, Italy
        • Policlinico- servizio di Ematologia
      • Napoli, Italy
        • Ospedale Cardarelli-ematologia e Trapianto di Midollo Osseo
      • Napoli, Italy
        • Ospedale Cardarelli-Sezione di Ematologia TERE
      • Napoli, Italy
        • Universita Federico II-Ema
      • Novara, Italy
        • Università Amedeo Avogrado-Ospedale Maggiore
      • Nuoro, Italy
        • Ospedale San Francesco
      • Orbassano, Italy
        • Osp San Luigi Gonzaga-Pat med
      • Padova, Italy
        • Ospedaliera di Pavona_Ematologia e
      • Palermo, Italy
        • Giaccone di Palermo
      • Pavia, Italy
        • Fondazione Maugeri
      • Pavia, Italy
        • Policlinico San Matteo
      • Perugia, Italy
        • Azienda Ospedaliera S. Maria della Misericordia
      • Pesaro, Italy
        • AO Ospedali Riunti Marche Nord
      • Pescara, Italy
        • Presidio Osp dello Spirito Santo
      • Ravenna, Italy
        • Osp S Maria delle Croci_Ema
      • Reggio Calabria, Italy
        • A.O. Bianchi Melacrino Morelli_Ops Riunti
      • Reggio Emilia, Italy
        • Azienda Ospedaliera S. Maria Nuova
      • Rimini, Italy
        • Ospedale Infermi
      • Rionero In Vulture, Italy
        • Ospedale Oncologica Regionale
      • Roma, Italy
        • Ospedale San Giovanni Addolorata
      • Roma, Italy
        • Azienda Osp S. Andrea
      • Roma, Italy
        • Inst Regina elena-SC Ema IFO
      • Roma, Italy
        • Osp. san Camillo Forlanini
      • Roma, Italy
        • Ospedale S Eugenio_Ema
      • Roma, Italy
        • UC Biomedico_Divisione di Ematologia
      • Roma, Italy
        • Universita La Sapienza_Ospedale Umberto I
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • Siena, Italy
        • AOU Senese Policlinico S. Maria alle Scotte
      • Taranto, Italy
        • PO SS Ann e S.G. Moscati-Ema
      • Terni, Italy
        • St. Maria_Oncoematologia
      • Torino, Italy
        • San Giovanni Battista Le Molinette-Ema 1
      • Torino, Italy
        • San Giovanni Battista Le Molinette-Ema 2
      • Tricase, Italy
        • AO Cardinale G. Panico
      • Trieste, Italy
        • AOU Ospedali Riuniti
      • Udine, Italy
        • AOU S.Maria della Misericordia
  • Luxembourg
      • Luxembourg, Luxembourg
        • LU-Luxembourg-CHL
  • Netherlands
      • Alkmaar, Netherlands
        • NL-Alkmaar-NWZ
      • Almere, Netherlands
        • NL-Almere-FLEVOZIEKENHUIS
      • Amersfoort, Netherlands
        • NL-Amersfoort-MEANDERMC
      • Amstelveen, Netherlands
        • NL-Amstelveen-AMSTELLAND
      • Amsterdam, Netherlands
        • NL-Amsterdam-AMC
      • Amsterdam, Netherlands
        • NL-Amsterdam-OLVG
      • Amsterdam, Netherlands
        • NL-Amsterdam-VUMC
      • Amsterdam, Netherlands
        • NL-Amsterdam-AVL
      • Apeldoorn, Netherlands
        • NL-Apeldoorn-GELREAPELDOORN
      • Arnhem, Netherlands
        • NL-Arnhem-RIJNSTATE
      • Assen, Netherlands
        • NL-Assen-WZA
      • Beverwijk, Netherlands
        • NL-Beverwijk-RKZ
      • Breda, Netherlands
        • NL-Breda-AMPHIA
      • Capelle Aan Den IJssel, Netherlands
        • NL-Capelle a/d IJssel-YSL
      • Delft, Netherlands
        • NL-Delft-RDGG
      • Den Bosch, Netherlands
        • NL-Den Bosch-JBZ
      • Den Haag, Netherlands
        • NL-Den Haag-HAGA
      • Deventer, Netherlands
        • NL-Deventer-DZ
      • Dirksland, Netherlands
        • NL-Dirksland-VANWEELBETHESDA
      • Doetinchem, Netherlands
        • NL-Doetinchem-SLINGELAND
      • Dordrecht, Netherlands
        • NL-Dordrecht-ASZ
      • Drachten, Netherlands
        • Nij Smellinghe
      • Ede, Netherlands
        • NL-Ede-ZGV
      • Eindhoven, Netherlands
        • NL-Eindhoven-CATHARINA
      • Eindhoven, Netherlands
        • NL-Eindhoven-MAXIMAMC
      • Emmen, Netherlands
        • NL-Emmen-SCHEPER
      • Enschede, Netherlands
        • NL-Enschede-MST
      • Geldrop, Netherlands
        • NL-Geldrop-STANNA
      • Goes, Netherlands
        • NL-Goes-ADRZ
      • Gorinchem, Netherlands
        • NL-Gorinchem-BEATRIX
      • Gouda, Netherlands
        • NL-Gouda-GROENEHART
      • Groningen, Netherlands
        • NL-Groningen-UMCG
      • Heerlen, Netherlands
        • NL-Heerlen-ATRIUMMC
      • Helmond, Netherlands
        • NL-Helmond-ELKERLIEK
      • Hilversum, Netherlands
        • NL-Hilversum-TERGOOI
      • Hoofddorp, Netherlands
        • NL-Hoofddorp-SPAARNEGASTHUIS
      • Hoorn, Netherlands
        • NL-Hoorn-DIJKLANDERHOORN
      • Leeuwarden, Netherlands
        • NL-Leeuwarden-MCL
      • Leiden, Netherlands
        • NL-Leiden-LUMC
      • Maastricht, Netherlands
        • NL-Maastricht-MUMC
      • Nieuwegein, Netherlands
        • NL-Nieuwegein-ANTONIUS
      • Nijmegen, Netherlands
        • NL-Nijmegen-CWZ
      • Nijmegen, Netherlands
        • NL-Nijmegen-RADBOUDUMC
      • Roermond, Netherlands
        • NL-Roermond-LZR
      • Roosendaal, Netherlands
        • NL-Roosendaal-BRAVIS
      • Rotterdam, Netherlands
        • NL-Rotterdam-ERASMUSMC
      • Rotterdam, Netherlands
        • NL-Rotterdam-IKAZIA
      • Rotterdam, Netherlands
        • NL-Rotterdam-MAASSTADZIEKENHUIS
      • Rotterdam, Netherlands
        • NL-Rotterdam-SFG
      • Rotterdam, Netherlands
        • NL-Rotterdam-EMCDANIEL
      • Sittard, Netherlands
        • NL-Sittard-Geleen-ZUYDERLAND
      • Spijkenisse, Netherlands
        • NL-Spijkenisse-SPIJKENISSEMC
      • Terneuzen, Netherlands
        • NL-Terneuzen-ZORGSAAM
      • Tilburg, Netherlands
        • NL-Tilburg-ETZ
      • Utrecht, Netherlands
        • NL-Utrecht-DIAKONESSENUTRECHT
      • Utrecht, Netherlands
        • NL-Utrecht-UMCUTRECHT
      • Venlo, Netherlands
        • NL-Venlo-VIECURI
      • Winterswijk, Netherlands
        • NL-Winterswijk-SKBWINTERSWIJK
      • Zwolle, Netherlands
        • NL-Zwolle-ISALA
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Førde, Norway
        • Forde Central Hosiptal
      • Harstad, Norway
        • Harstad University Hospital
      • Kristiansand, Norway
        • Sørlandet Hospital
      • Levanger, Norway
        • Levanger Hospital
      • Lørenskog, Norway
        • NO-Lørenskog-AKERSHUS
      • Oslo, Norway
        • NO-Oslo-OSLOUH
      • Sandvika, Norway
        • Baerum Hospital
      • Stavanger, Norway
        • NO-Stavanger-HELSESTAVANGER
      • Tromsø, Norway
        • NO-Tromsø-NORTHNOORWEGEN
      • Trondheim, Norway
        • NO-Trondheim-STOLAV
      • Ålesund, Norway
        • Helse Sunnmore
  • Portugal
      • Lisboa, Portugal
        • Francisco Gentil
  • Sweden
      • Borås, Sweden
        • SE-Boras-SASBORAS
      • Eskilstuna, Sweden
        • Eskilstuna Malar Hospital
      • Falun, Sweden
        • Falun hospital
      • Göteborg, Sweden
        • Sahlgrenska University Hospital
      • Halmstad, Sweden
        • Hallands Hospital Halmstad
      • Helsingborg, Sweden
        • Helsingborg General Hospital
      • Jönköping, Sweden
        • Ryhov Hospital
      • Lidkoping, Sweden
        • Lidkoping Hospital
      • Linköping, Sweden
        • SE-Linköping-REGIONOSTERGOTLAND
      • Luleå, Sweden
        • SE-Luleå-SUNDERBY
      • Lund, Sweden
        • SE-Lund-SUH
      • Stockholm, Sweden
        • SE-Stockholm-KAROLINSKAHUDDINGE
      • Sundsvall, Sweden
        • Sundsvall Hospital
      • Uddevalla, Sweden
        • Uddevall Hospital
      • Umeå, Sweden
        • Umeå University Hospital
      • Uppsala, Sweden
        • SE-Uppsala-UPPSALAUH
      • Växjö, Sweden
        • Centrallasareltet Vaxjo
      • Örebro, Sweden
        • Orebro University Hospital
  • Switzerland
      • Aarau, Switzerland
        • CH-Aarau-KSA
      • Basel, Switzerland
        • CH-Basel-USB
      • Bellinzona, Switzerland
        • CH-Bellinzona-IOSI
      • Bern, Switzerland
        • CH-Bern-INSEL
      • Chur, Switzerland
        • KS Graubunden
      • Geneve, Switzerland
        • CH-Geneve (14)-HCUGE
      • Liestal, Switzerland
        • Kantonsspital Baselland
      • Luzern, Switzerland
        • CH-Luzern-LUKS
      • Saint Gallen, Switzerland
        • CH-St. Gallen-KSSG
      • Zürich, Switzerland
        • CH-Zürich-USZ
  • Turkey
      • Adana, Turkey
        • Baskent University Hospital
      • Ankara, Turkey
        • Gazi University Hospital
      • Ankara, Turkey
        • University Hospital Ankara
      • Istanbul, Turkey
        • Istanbul University Hospital
      • Kayseri, Turkey
        • Erciyes University Hospital
      • İzmir, Turkey
        • Ege University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present;
  • Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein> 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light chain ratio;
  • Age 18-65 years inclusive;
  • WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions);
  • Negative pregnancy test at inclusion if applicable;
  • Written informed consent.

Inclusion for randomisation 1:

  • WHO performance 0-2;
  • Bilirubin and transaminases < 2.5 times the upper limit of normal values;
  • A suitable stem cell graft containing at least 4 x 106 CD34+ cells/kg (or according to national guidelines).

Inclusion for randomisation 2:

  • Bilirubin and transaminases < 2.5 times the upper limit of normal values;
  • ANC >= 0.5 x 109/l and platelets > 20 x 10^9/l;
  • Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.

Exclusion Criteria:

  • Known intolerance of Boron;
  • Systemic AL amyloidosis;
  • Primary Plasmacell Leukemia;
  • Non-secretory MM;
  • Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;
  • Severe cardiac dysfunction (NYHA classification II-IV);
  • Significant hepatic dysfunction, unless related to myeloma;
  • Patients with GFR <15 ml/min,
  • Patients known to be HIV-positive;
  • Patients with active, uncontrolled infections;
  • Patients with neuropathy, CTC grade 2 or higher;
  • Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
  • Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
  • Lactating women.

Exclusion for randomisation 1:

  • Severe pulmonary, neurologic, or psychiatric disease;
  • CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;
  • Allogeneic Stem Cell Transplantation (Allo SCT) planned;
  • Progressive disease.'

Exclusion for randomisation 2:

  • Progressive disease;
  • Neuropathy, except CTCAE grade 1;
  • CTCAE grade 3-4 polyneuropathy during Bortezomib treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)
All patients randomized to VMP treatment, will be treated with Bortezomib, Melphalan, Prednisone(VMP, 4 cycles) and will start intensification with VMP between 4 and 6 weeks after stem cell collection.
Drug: Bortezomib, Melphalan, Prednisone (VMP)
  • Bortezomib _ 1.3 mg/m2 _ i.v. rapid infusion _ days 1,4,8,11,22,25,29,32
  • Melphalan _ 9 mg/m² _ p.o. _ days 1-4
  • Prednisone _ 60 mg/m² _ p.o. _ days 1-4
Experimental: R1: 1 (2) cycle(s) HDM
All patients randomized to intensification with High Dose Melphalan will start intensification with HDM (in hospitals with a policy of double intensification, patients will be randomized between VMP, 1 HDM and 2 HDM) between 4 and 6 weeks after stem cell collection.
Drug: 1 or 2 cycle(s) HDM (High Dose Melphalan)

- Melphalan _ 100 mg/m² _ i.v. rapid infusion _ -3, -2*

*Patients with renal insufficiency 100 mg/m2 only at day -3

If a patient is randomized to receive 2 x HDM a second course of High Dose Melphalan may be administered between 2 and 3 months after the first course when the patient achieved at least PR.
No Intervention: R2: none
No consolidation, patients will continue to Lenalidomide maintenance.
Experimental: R2: 2 cycles of VRD
In patients randomized to consolidation treatment, 2 cycles of Bortezomib, Lenalidomide,Dexamethasone (VRD) will start at 8 weeks after the end of the last course of VMP or HDM.
Drug: 2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)
  • Bortezomib _ 1.3 mg/m2 _ i.v. rapid infusion _ days 1,4,8,11
  • Lenalidomide _ 25 mg _ p.o. _ days 1-21
  • Dexamethasone _ 20 mg _ p.o. _ days 1,2,4,5,8,9,11,12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
Time Frame: end of trial (last patient last visit)
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
end of trial (last patient last visit)
For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
Time Frame: end of trial (last patient last visit)
For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
end of trial (last patient last visit)
For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
Time Frame: end of trial (last patient last visit)
For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
end of trial (last patient last visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
Time Frame: end of trial (last patient last visit)

Overall survival measured from the time of registration /randomization R1/ randomization R2.

Patients still alive or lost to follow up are censored at the date they were last known to be alive.
end of trial (last patient last visit)
Toxicity
Time Frame: End of trial (last patient last visit)
Toxicity
End of trial (last patient last visit)
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
Time Frame: end of trial (last patient last visit)
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
end of trial (last patient last visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborators

European Myeloma Network
Gruppo Italiano Malattie EMatologiche dell'Adulto
DSMM (Deutsche Studiengruppe Multiples Myelom)
NMSG (Nordic Myeloma Study Group)
Central European Myeloma Study Group

Investigators

  • Principal Investigator: Pieter Sonneveld, Prof., Stichting Hemato-Oncologie voor Volwassenen Nederland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 1, 2020

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimated)

September 24, 2010

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOVON 95 MM
  • 2009-017903-28 (EudraCT Number)
  • EMN02 (Other Identifier: European Myeloma Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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