Clinical trial NCT01208766: Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma (Kahler's disease)
Lead sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
Sponsor class: OTHER
Collaborators: name: Stichting European Myeloma Network
name: Gruppo Italiano Malattie EMatologiche dell'Adulto
name: DSMM (Deutsche Studiengruppe Multiples Myelom)
name: NMSG (Nordic Myeloma Study Group)
name: Central European Myeloma Study Group
First posted: 2010-09-24
Enrollment: 1503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
timeFrame: end of trial (last patient last visit)
measure: For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
timeFrame: end of trial (last patient last visit)
measure: For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
timeFrame: end of trial (last patient last visit)
Secondary outcomes:
measure: 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.
timeFrame: end of trial (last patient last visit)
measure: Toxicity
timeFrame: End of trial (last patient last visit)
measure: Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
timeFrame: end of trial (last patient last visit)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: AU-Brisbane-PAH
city: Canberra
country: Australia
facility: AU-Canberra-CANBERRAHOSPITAL
city: Melbourne
country: Australia
facility: AU-Melbourne-ALFRED
city: Sydney
country: Australia
facility: AU-Sydney-CONCORD
city: Sydney
country: Australia
facility: AU-Sydney-NEPEAN
city: Sydney
country: Australia
facility: Prince of Wales Hospital
city: Sydney
country: Australia
facility: St George Hospital
city: Linz
country: Austria
facility: Krankenhaus d.Elisabethinen
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Vienna
country: Austria
facility: AT-Vienna-HANUSCH
city: Antwerpen
country: Belgium
facility: BE-Antwerpen Edegem-UZA
city: Antwerpen
country: Belgium
facility: BE-Antwerpen-ZNASTUIVENBERG
city: Haine-Saint-Paul
country: Belgium
facility: BE-Haine-Saint-Paul-JOLIMONT
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Liège
country: Belgium
facility: BE-Liege-CHRCITADELLE
city: Mons
country: Belgium
facility: BE-Mons-AMBROISE
city: Mons
country: Belgium
facility: CHR Saint Joseph
city: Roeselare
country: Belgium
facility: BE-Roeselare-AZDELTA
city: Saint-Ghislain
country: Belgium
facility: RHMS
city: Tournai
country: Belgium
facility: CH Wapi
city: Turnhout
country: Belgium
facility: AZ Turnhout
city: Brno
country: Czechia
facility: CZ-Brno-UHBRNO
city: Hradec
country: Czechia
facility: Kralove-University Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: CZ-Olomouc-FNOL
city: Ostrava
country: Czechia
facility: CZ-Ostrava-Poruba-FNO
city: Plzen
country: Czechia
facility: University Hospital Plzen
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Aalborg
country: Denmark
facility: DK-Aalborg-AALBORGUH
city: Aarhus
country: Denmark
facility: DK-Aarhus N-AUH
city: Copenhagen
country: Denmark
facility: DK-Copenhagen-RIGSHOSPITALET
city: Herlev
country: Denmark
facility: DK-Herlev-HERLEV
city: Odense
country: Denmark
facility: DK-Odense-OUH
city: Roskilde
country: Denmark
facility: DK-Roskilde-ROSKILDE
city: Turku
country: Finland
facility: FI-Turku-TYKS
city: Athens
country: Greece
facility: GR-Athens-ALEXANDRA
city: Budapest
country: Hungary
facility: St. Istvan and St. Laszlo Korhaz Hospital
city: Szeged
country: Hungary
facility: Szeged University Hospital
city: Alessandria
country: Italy
facility: SS Antonio e Biogio
city: Ancona
country: Italy
facility: AOU Umberto I-Clinica di Ematologica
city: Ascoli Piceno
country: Italy
facility: Ospedale C. e G. Mazzoni-Ematologia
city: Avellino
country: Italy
facility: A.O.R.N. San G. Moscati
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bergamo
country: Italy
facility: Oaspedali Riuniti_Div di Ematologia
city: Bologna
country: Italy
facility: Instituto di Ematologia e Oncologia Medica
city: Bolzano
country: Italy
facility: Ospedale Generale Regionale_Div di Ema e Centro
city: Brescia
country: Italy
facility: Spedali Civili_U.O.Ematologia
city: Brindisi
country: Italy
facility: Pres Osp Di Summa
city: Cagliari
country: Italy
facility: Presidio Osp R. Binaghi
city: Candiolo
country: Italy
facility: Inst per la Ricerca e la Cura del Cancro Di
city: Catania
country: Italy
facility: Ospedale Ferrarotto-Ema
city: Cosenza
country: Italy
facility: Presidio ospedaliero dell'annunziata
city: Cuneo
country: Italy
facility: OspedaleCivico S Croce e carle
city: Foggia
country: Italy
facility: Ospedali Riuniti di Foggia
city: Gallarate
country: Italy
facility: Azienda Ospedaliera San Antonio Abate
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria S. Martino_Clinica Ematologica
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria S. Martino_Ematologia 1
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria S. Martino_Ematologia 2
city: Latina
country: Italy
facility: Università La Sapienza Polo Pontino
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Marche
country: Italy
facility: ASUR Regione Marche
city: Meldola
country: Italy
facility: IRST
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo
city: Messina
country: Italy
facility: Policlinico Gaetano Martino
city: Mestre
country: Italy
facility: Osp Dell Angelo
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori-Ema
city: Milano
country: Italy
facility: Ospedale Niguarda Cà Grande
city: Modena
country: Italy
facility: Policlinico- servizio di Ematologia
city: Napoli
country: Italy
facility: Ospedale Cardarelli-ematologia e Trapianto di Midollo Osseo
city: Napoli
country: Italy
facility: Ospedale Cardarelli-Sezione di Ematologia TERE
city: Napoli
country: Italy
facility: Universita Federico II-Ema
city: Novara
country: Italy
facility: Università Amedeo Avogrado-Ospedale Maggiore
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Orbassano
country: Italy
facility: Osp San Luigi Gonzaga-Pat med
city: Padova
country: Italy
facility: Ospedaliera di Pavona_Ematologia e
city: Palermo
country: Italy
facility: Giaccone di Palermo
city: Pavia
country: Italy
facility: Fondazione Maugeri
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Perugia
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia
city: Pesaro
country: Italy
facility: AO Ospedali Riunti Marche Nord
city: Pescara
country: Italy
facility: Presidio Osp dello Spirito Santo
city: Ravenna
country: Italy
facility: Osp S Maria delle Croci_Ema
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi Melacrino Morelli_Ops Riunti
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera S. Maria Nuova
city: Rimini
country: Italy
facility: Ospedale Infermi
city: Rionero In Vulture
country: Italy
facility: Ospedale Oncologica Regionale
city: Roma
country: Italy
facility: Azienda Osp S. Andrea
city: Roma
country: Italy
facility: Inst Regina elena-SC Ema IFO
city: Roma
country: Italy
facility: Osp. san Camillo Forlanini
city: Roma
country: Italy
facility: Ospedale S Eugenio_Ema
city: Roma
country: Italy
facility: Ospedale San Giovanni Addolorata
city: Roma
country: Italy
facility: UC Biomedico_Divisione di Ematologia
city: Roma
country: Italy
facility: Universita La Sapienza_Ospedale Umberto I
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Siena
country: Italy
facility: AOU Senese Policlinico S. Maria alle Scotte
city: Taranto
country: Italy
facility: PO SS Ann e S.G. Moscati-Ema
city: Terni
country: Italy
facility: St. Maria_Oncoematologia
city: Torino
country: Italy
facility: San Giovanni Battista Le Molinette-Ema 1
city: Torino
country: Italy
facility: San Giovanni Battista Le Molinette-Ema 2
city: Tricase
country: Italy
facility: AO Cardinale G. Panico
city: Trieste
country: Italy
facility: AOU Ospedali Riuniti
city: Udine
country: Italy
facility: AOU S.Maria della Misericordia
city: Luxembourg
country: Luxembourg
facility: LU-Luxembourg-CHL
city: Alkmaar
country: Netherlands
facility: NL-Alkmaar-NWZ
city: Almere
country: Netherlands
facility: NL-Almere-FLEVOZIEKENHUIS
city: Amersfoort
country: Netherlands
facility: NL-Amersfoort-MEANDERMC
city: Amstelveen
country: Netherlands
facility: NL-Amstelveen-AMSTELLAND
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-AMC
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-AVL
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-OLVG
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-VUMC
city: Apeldoorn
country: Netherlands
facility: NL-Apeldoorn-GELREAPELDOORN
city: Arnhem
country: Netherlands
facility: NL-Arnhem-RIJNSTATE
city: Assen
country: Netherlands
facility: NL-Assen-WZA
city: Beverwijk
country: Netherlands
facility: NL-Beverwijk-RKZ
city: Breda
country: Netherlands
facility: NL-Breda-AMPHIA
city: Capelle Aan Den IJssel
country: Netherlands
facility: NL-Capelle a/d IJssel-YSL
city: Delft
country: Netherlands
facility: NL-Delft-RDGG
city: Den Bosch
country: Netherlands
facility: NL-Den Bosch-JBZ
city: Den Haag
country: Netherlands
facility: NL-Den Haag-HAGA
city: Deventer
country: Netherlands
facility: NL-Deventer-DZ
city: Dirksland
country: Netherlands
facility: NL-Dirksland-VANWEELBETHESDA
city: Doetinchem
country: Netherlands
facility: NL-Doetinchem-SLINGELAND
city: Dordrecht
country: Netherlands
facility: NL-Dordrecht-ASZ
city: Drachten
country: Netherlands
facility: Nij Smellinghe
city: Ede
country: Netherlands
facility: NL-Ede-ZGV
city: Eindhoven
country: Netherlands
facility: NL-Eindhoven-CATHARINA
city: Eindhoven
country: Netherlands
facility: NL-Eindhoven-MAXIMAMC
city: Emmen
country: Netherlands
facility: NL-Emmen-SCHEPER
city: Enschede
country: Netherlands
facility: NL-Enschede-MST
city: Geldrop
country: Netherlands
facility: NL-Geldrop-STANNA
city: Goes
country: Netherlands
facility: NL-Goes-ADRZ
city: Gorinchem
country: Netherlands
facility: NL-Gorinchem-BEATRIX
city: Gouda
country: Netherlands
facility: NL-Gouda-GROENEHART
city: Groningen
country: Netherlands
facility: NL-Groningen-UMCG
city: Heerlen
country: Netherlands
facility: NL-Heerlen-ATRIUMMC
city: Helmond
country: Netherlands
facility: NL-Helmond-ELKERLIEK
city: Hilversum
country: Netherlands
facility: NL-Hilversum-TERGOOI
city: Hoofddorp
country: Netherlands
facility: NL-Hoofddorp-SPAARNEGASTHUIS
city: Hoorn
country: Netherlands
facility: NL-Hoorn-DIJKLANDERHOORN
city: Leeuwarden
country: Netherlands
facility: NL-Leeuwarden-MCL
city: Leiden
country: Netherlands
facility: NL-Leiden-LUMC
city: Maastricht
country: Netherlands
facility: NL-Maastricht-MUMC
city: Nieuwegein
country: Netherlands
facility: NL-Nieuwegein-ANTONIUS
city: Nijmegen
country: Netherlands
facility: NL-Nijmegen-CWZ
city: Nijmegen
country: Netherlands
facility: NL-Nijmegen-RADBOUDUMC
city: Roermond
country: Netherlands
facility: NL-Roermond-LZR
city: Roosendaal
country: Netherlands
facility: NL-Roosendaal-BRAVIS
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-EMCDANIEL
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-ERASMUSMC
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-IKAZIA
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-MAASSTADZIEKENHUIS
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-SFG
city: Sittard
country: Netherlands
facility: NL-Sittard-Geleen-ZUYDERLAND
city: Spijkenisse
country: Netherlands
facility: NL-Spijkenisse-SPIJKENISSEMC
city: Terneuzen
country: Netherlands
facility: NL-Terneuzen-ZORGSAAM
city: Tilburg
country: Netherlands
facility: NL-Tilburg-ETZ
city: Utrecht
country: Netherlands
facility: NL-Utrecht-DIAKONESSENUTRECHT
city: Utrecht
country: Netherlands
facility: NL-Utrecht-UMCUTRECHT
city: Venlo
country: Netherlands
facility: NL-Venlo-VIECURI
city: Winterswijk
country: Netherlands
facility: NL-Winterswijk-SKBWINTERSWIJK
city: Zwolle
country: Netherlands
facility: NL-Zwolle-ISALA
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Førde
country: Norway
facility: Forde Central Hosiptal
city: Harstad
country: Norway
facility: Harstad University Hospital
city: Kristiansand
country: Norway
facility: Sørlandet Hospital
city: Levanger
country: Norway
facility: Levanger Hospital
city: Lørenskog
country: Norway
facility: NO-Lørenskog-AKERSHUS
city: Oslo
country: Norway
facility: NO-Oslo-OSLOUH
city: Sandvika
country: Norway
facility: Baerum hospital
city: Stavanger
country: Norway
facility: NO-Stavanger-HELSESTAVANGER
city: Tromsø
country: Norway
facility: NO-Tromsø-NORTHNOORWEGEN
city: Trondheim
country: Norway
facility: NO-Trondheim-STOLAV
city: Ålesund
country: Norway
facility: Helse Sunnmore
city: Lisboa
country: Portugal
facility: Francisco Gentil
city: Borås
country: Sweden
facility: SE-Boras-SASBORAS
city: Eskilstuna
country: Sweden
facility: Eskilstuna Malar Hospital
city: Falun
country: Sweden
facility: Falun Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
city: Helsingborg
country: Sweden
facility: Helsingborg General Hospital
city: Jönköping
country: Sweden
facility: Ryhov Hospital
city: Lidkoping
country: Sweden
facility: Lidkoping Hospital
city: Linköping
country: Sweden
facility: SE-Linköping-REGIONOSTERGOTLAND
city: Luleå
country: Sweden
facility: SE-Luleå-SUNDERBY
city: Lund
country: Sweden
facility: SE-Lund-SUH
city: Stockholm
country: Sweden
facility: SE-Stockholm-KAROLINSKAHUDDINGE
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Uddevalla
country: Sweden
facility: Uddevall Hospital
city: Umeå
country: Sweden
facility: Umea University Hospital
city: Uppsala
country: Sweden
facility: SE-Uppsala-UPPSALAUH
city: Växjö
country: Sweden
facility: Centrallasareltet Vaxjo
city: Örebro
country: Sweden
facility: Orebro University Hospital
city: Aarau
country: Switzerland
facility: CH-Aarau-KSA
city: Basel
country: Switzerland
facility: CH-Basel-USB
city: Bellinzona
country: Switzerland
facility: CH-Bellinzona-IOSI
city: Bern
country: Switzerland
facility: CH-Bern-INSEL
city: Chur
country: Switzerland
facility: KS Graubunden
city: Geneve
country: Switzerland
facility: CH-Geneve (14)-HCUGE
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Luzern
country: Switzerland
facility: CH-Luzern-LUKS
city: Saint Gallen
country: Switzerland
facility: CH-St. Gallen-KSSG
city: Zürich
country: Switzerland
facility: CH-Zürich-USZ
city: Adana
country: Turkey
facility: Baskent University Hospital
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Ankara
country: Turkey
facility: University Hospital Ankara
city: Istanbul
country: Turkey
facility: Istanbul University Hospital
city: İzmir
country: Turkey
facility: Ege University Hospital
city: Kayseri
country: Turkey
facility: Erciyes University Hospital
Study officials:
affiliation: Stichting Hemato-Oncologie voor Volwassenen Nederland
name: Pieter Sonneveld, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitz A, Brondum RF, Johnsen HE, Mellqvist UH, Waage A, Gimsing P, Op Bruinink DH, van der Velden V, van der Holt B, Hansson M, Andersen NF, Frolund UC, Helleberg C, Schjesvold FH, Ahlberg L, Gulbrandsen N, Andreasson B, Lauri B, Haukas E, Bodker JS, Roug AS, Bogsted M, Severinsen MT, Gregersen H, Abildgaard N, Sonneveld P, Dybkaer K. Longitudinal minimal residual disease assessment in multiple myeloma patients in complete remission - results from the NMSG flow-MRD substudy within the EMN02/HO95 MM trial. BMC Cancer. 2022 Feb 5;22(1):147. doi: 10.1186/s12885-022-09184-1.
citation: Sonneveld P, Dimopoulos MA, Beksac M, van der Holt B, Aquino S, Ludwig H, Zweegman S, Zander T, Zamagni E, Wester R, Hajek R, Pantani L, Dozza L, Gay F, Cafro A, De Rosa L, Morelli A, Gregersen H, Gulbrandsen N, Cornelisse P, Troia R, Oliva S, van de Velden V, Wu K, Ypma PF, Bos G, Levin MD, Pour L, Driessen C, Broijl A, Croockewit A, Minnema MC, Waage A, Hveding C, van de Donk NWCJ, Offidani M, Palumbo GA, Spencer A, Boccadoro M, Cavo M. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Nov 10;39(32):3613-3622. doi: 10.1200/JCO.21.01045. Epub 2021 Sep 14.
citation: Cavo M, Gay F, Beksac M, Pantani L, Petrucci MT, Dimopoulos MA, Dozza L, van der Holt B, Zweegman S, Oliva S, van der Velden VHJ, Zamagni E, Palumbo GA, Patriarca F, Montefusco V, Galli M, Maisnar V, Gamberi B, Hansson M, Belotti A, Pour L, Ypma P, Grasso M, Croockewit A, Ballanti S, Offidani M, Vincelli ID, Zambello R, Liberati AM, Andersen NF, Broijl A, Troia R, Pascarella A, Benevolo G, Levin MD, Bos G, Ludwig H, Aquino S, Morelli AM, Wu KL, Boersma R, Hajek R, Durian M, von dem Borne PA, Caravita di Toritto T, Zander T, Driessen C, Specchia G, Waage A, Gimsing P, Mellqvist UH, van Marwijk Kooy M, Minnema M, Mandigers C, Cafro AM, Palmas A, Carvalho S, Spencer A, Boccadoro M, Sonneveld P. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020 Jun;7(6):e456-e468. doi: 10.1016/S2352-3026(20)30099-5. Epub 2020 Apr 30.
citation: Gambella M, Omede P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.