Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
HO95
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
3 other identifiers
interventional
1,503
15 countries
205
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Jan 2011
Longer than P75 for phase_3 multiple-myeloma
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJanuary 6, 2026
October 1, 2025
9.9 years
September 23, 2010
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
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
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
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 Outcomes (3)
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
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)
Study Arms (4)
R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)
ACTIVE COMPARATORAll 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.
R1: 1 (2) cycle(s) HDM
EXPERIMENTALAll 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.
R2: none
NO INTERVENTIONNo consolidation, patients will continue to Lenalidomide maintenance.
R2: 2 cycles of VRD
EXPERIMENTALIn 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.
Interventions
* 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
\- 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.
* 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
Eligibility Criteria
You may qualify if:
- 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);
- Written informed consent.
- 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).
- 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.
You may not qualify if:
- 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.
- Severe pulmonary, neurologic, or psychiatric disease;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stichting Hemato-Oncologie voor Volwassenen Nederlandlead
- European Myeloma Network B.V.collaborator
- Gruppo Italiano Malattie EMatologiche dell'Adultocollaborator
- DSMM (Deutsche Studiengruppe Multiples Myelom)collaborator
- NMSG (Nordic Myeloma Study Group)collaborator
- Central European Myeloma Study Groupcollaborator
Study Sites (208)
AU-Brisbane-PAH
Brisbane, Australia
AU-Canberra-CANBERRAHOSPITAL
Canberra, Australia
AU-Melbourne-ALFRED
Melbourne, Australia
AU-Sydney-CONCORD
Sydney, Australia
AU-Sydney-NEPEAN
Sydney, Australia
Prince of Wales Hospital
Sydney, Australia
St George Hospital
Sydney, Australia
Krankenhaus d.Elisabethinen
Linz, Austria
Landeskrankenhaus Salzburg
Salzburg, Austria
AT-Vienna-HANUSCH
Vienna, Austria
BE-Antwerpen Edegem-UZA
Antwerp, Belgium
BE-Antwerpen-ZNASTUIVENBERG
Antwerp, Belgium
BE-Haine-Saint-Paul-JOLIMONT
Haine-Saint-Paul, Belgium
CHU Tivoli
La Louvière, Belgium
BE-Liege-CHRCITADELLE
Liège, Belgium
BE-Mons-AMBROISE
Mons, Belgium
CHR Saint Joseph
Mons, Belgium
BE-Roeselare-AZDELTA
Roeselare, Belgium
RHMS
Saint-Ghislain, Belgium
CH Wapi
Tournai, Belgium
AZ Turnhout
Turnhout, Belgium
CZ-Brno-UHBRNO
Brno, Czechia
Kralove-University Hospital Hradec Kralove
Hradec, Czechia
CZ-Olomouc-FNOL
Olomouc, Czechia
CZ-Ostrava-Poruba-FNO
Ostrava, Czechia
University Hospital Plzen
Pilsen, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
DK-Aalborg-AALBORGUH
Aalborg, Denmark
DK-Aarhus N-AUH
Aarhus, Denmark
DK-Copenhagen-RIGSHOSPITALET
Copenhagen, Denmark
DK-Herlev-HERLEV
Herlev, Denmark
DK-Odense-OUH
Odense, Denmark
DK-Roskilde-ROSKILDE
Roskilde, Denmark
FI-Turku-TYKS
Turku, Finland
GR-Athens-ALEXANDRA
Athens, Greece
St. Istvan and St. Laszlo Korhaz Hospital
Budapest, Hungary
Szeged University Hospital
Szeged, Hungary
SS Antonio e Biogio
Alessandria, Italy
AOU Umberto I-Clinica di Ematologica
Ancona, Italy
Ospedale C. e G. Mazzoni-Ematologia
Ascoli Piceno, Italy
A.O.R.N. San G. Moscati
Avellino, Italy
Policlinico di Bari
Bari, Italy
Oaspedali Riuniti_Div di Ematologia
Bergamo, Italy
Instituto di Ematologia e Oncologia Medica
Bologna, Italy
Ospedale Generale Regionale_Div di Ema e Centro
Bolzano, Italy
Spedali Civili_U.O.Ematologia
Brescia, Italy
Pres Osp Di Summa
Brindisi, Italy
Presidio Osp R. Binaghi
Cagliari, Italy
Inst per la Ricerca e la Cura del Cancro Di
Candiolo, Italy
Ospedale Ferrarotto-Ema
Catania, Italy
Presidio ospedaliero dell'annunziata
Cosenza, Italy
OspedaleCivico S Croce e carle
Cuneo, Italy
Ospedali Riuniti di Foggia
Foggia, Italy
Azienda Ospedaliera San Antonio Abate
Gallarate, 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
Genova, Italy
Università La Sapienza Polo Pontino
Latina, Italy
Ospedale A. Manzoni
Lecco, Italy
ASUR Regione Marche
Marche, Italy
IRST
Meldola, Italy
Azienda Ospedaliera Papardo
Messina, Italy
Policlinico Gaetano Martino
Messina, Italy
Osp Dell Angelo
Mestre, Italy
Istituto Nazionale dei Tumori-Ema
Milan, Italy
Ospedale Niguarda Cà Grande
Milan, Italy
Policlinico- servizio di Ematologia
Modena, Italy
Ospedale Cardarelli-ematologia e Trapianto di Midollo Osseo
Naples, Italy
Ospedale Cardarelli-Sezione di Ematologia TERE
Naples, Italy
Universita Federico II-Ema
Naples, Italy
Università Amedeo Avogrado-Ospedale Maggiore
Novara, Italy
Ospedale San Francesco
Nuoro, Italy
Osp San Luigi Gonzaga-Pat med
Orbassano, Italy
Ospedaliera di Pavona_Ematologia e
Padua, Italy
Giaccone di Palermo
Palermo, Italy
Fondazione Maugeri
Pavia, Italy
Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera S. Maria della Misericordia
Perugia, Italy
AO Ospedali Riunti Marche Nord
Pesaro, Italy
Presidio Osp dello Spirito Santo
Pescara, Italy
Osp S Maria delle Croci_Ema
Ravenna, Italy
A.O. Bianchi Melacrino Morelli_Ops Riunti
Reggio Calabria, Italy
Azienda Ospedaliera S. Maria Nuova
Reggio Emilia, Italy
Ospedale Infermi
Rimini, Italy
Ospedale Oncologica Regionale
Rionero in Vulture, 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
Ospedale San Giovanni Addolorata
Roma, Italy
UC Biomedico_Divisione di Ematologia
Roma, Italy
Universita La Sapienza_Ospedale Umberto I
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
AOU Senese Policlinico S. Maria alle Scotte
Siena, Italy
PO SS Ann e S.G. Moscati-Ema
Taranto, Italy
St. Maria_Oncoematologia
Terni, Italy
San Giovanni Battista Le Molinette-Ema 1
Torino, Italy
San Giovanni Battista Le Molinette-Ema 2
Torino, Italy
AO Cardinale G. Panico
Tricase, Italy
AOU Ospedali Riuniti
Trieste, Italy
AOU S.Maria della Misericordia
Udine, Italy
LU-Luxembourg-CHL
Luxembourg, Luxembourg
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
NL-Alkmaar-NWZ
Alkmaar, Netherlands
NL-Almere-FLEVOZIEKENHUIS
Almere Stad, Netherlands
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
NL-Amstelveen-AMSTELLAND
Amstelveen, Netherlands
NL-Amsterdam-AMC
Amsterdam, Netherlands
NL-Amsterdam-AVL
Amsterdam, Netherlands
NL-Amsterdam-OLVG
Amsterdam, Netherlands
NL-Amsterdam-VUMC
Amsterdam, Netherlands
NL-Apeldoorn-GELREAPELDOORN
Apeldoorn, Netherlands
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
NL-Assen-WZA
Assen, Netherlands
NL-Beverwijk-RKZ
Beverwijk, Netherlands
NL-Breda-AMPHIA
Breda, Netherlands
NL-Capelle a/d IJssel-YSL
Capelle aan den IJssel, Netherlands
NL-Delft-RDGG
Delft, Netherlands
NL-Deventer-DZ
Deventer, Netherlands
NL-Dirksland-VANWEELBETHESDA
Dirksland, Netherlands
NL-Doetinchem-SLINGELAND
Doetinchem, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Nij Smellinghe
Drachten, Netherlands
NL-Ede-ZGV
Ede, Netherlands
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
NL-Emmen-SCHEPER
Emmen, Netherlands
NL-Enschede-MST
Enschede, Netherlands
NL-Geldrop-STANNA
Geldrop, Netherlands
NL-Goes-ADRZ
Goes, Netherlands
NL-Gorinchem-BEATRIX
Gorinchem, Netherlands
NL-Gouda-GROENEHART
Gouda, Netherlands
NL-Groningen-UMCG
Groningen, Netherlands
NL-Heerlen-ATRIUMMC
Heerlen, Netherlands
NL-Helmond-ELKERLIEK
Helmond, Netherlands
NL-Hilversum-TERGOOI
Hilversum, Netherlands
NL-Hoofddorp-SPAARNEGASTHUIS
Hoofddorp, Netherlands
NL-Hoorn-DIJKLANDERHOORN
Hoorn, Netherlands
NL-Leeuwarden-MCL
Leeuwarden, Netherlands
NL-Leiden-LUMC
Leiden, Netherlands
NL-Maastricht-MUMC
Maastricht, Netherlands
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
NL-Nijmegen-CWZ
Nijmegen, Netherlands
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
NL-Roermond-LZR
Roermond, Netherlands
NL-Roosendaal-BRAVIS
Roosendaal, Netherlands
NL-Rotterdam-EMCDANIEL
Rotterdam, Netherlands
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
NL-Rotterdam-IKAZIA
Rotterdam, Netherlands
NL-Rotterdam-MAASSTADZIEKENHUIS
Rotterdam, Netherlands
NL-Rotterdam-SFG
Rotterdam, Netherlands
NL-Sittard-Geleen-ZUYDERLAND
Sittard, Netherlands
NL-Spijkenisse-SPIJKENISSEMC
Spijkenisse, Netherlands
NL-Terneuzen-ZORGSAAM
Terneuzen, Netherlands
NL-Den Haag-HAGA
The Hague, Netherlands
NL-Tilburg-ETZ
Tilburg, Netherlands
NL-Utrecht-DIAKONESSENUTRECHT
Utrecht, Netherlands
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
NL-Venlo-VIECURI
Venlo, Netherlands
NL-Winterswijk-SKBWINTERSWIJK
Winterswijk, Netherlands
NL-Zwolle-ISALA
Zwolle, Netherlands
Helse Sunnmore
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Forde Central Hosiptal
Førde, Norway
Harstad University Hospital
Harstad, Norway
Sørlandet Hospital
Kristiansand, Norway
Levanger Hospital
Levanger, Norway
NO-Lørenskog-AKERSHUS
Lørenskog, Norway
NO-Oslo-OSLOUH
Oslo, Norway
Baerum hospital
Sandvika, Norway
NO-Stavanger-HELSESTAVANGER
Stavanger, Norway
NO-Tromsø-NORTHNOORWEGEN
Tromsø, Norway
NO-Trondheim-STOLAV
Trondheim, Norway
Francisco Gentil
Lisbon, Portugal
SE-Boras-SASBORAS
Borås, Sweden
Eskilstuna Malar Hospital
Eskilstuna, Sweden
Falun Hospital
Falun, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Hallands Hospital Halmstad
Halmstad, Sweden
Helsingborg General Hospital
Helsingborg, Sweden
Ryhov Hospital
Jönköping, Sweden
Lidkoping Hospital
Lidköping, Sweden
SE-Linköping-REGIONOSTERGOTLAND
Linköping, Sweden
SE-Luleå-SUNDERBY
Luleå, Sweden
SE-Lund-SUH
Lund, Sweden
Orebro University Hospital
Örebro, Sweden
SE-Stockholm-KAROLINSKAHUDDINGE
Stockholm, Sweden
Sundsvall Hospital
Sundsvall, Sweden
Uddevall Hospital
Uddevalla, Sweden
Umea University Hospital
Umeå, Sweden
SE-Uppsala-UPPSALAUH
Uppsala, Sweden
Centrallasareltet Vaxjo
Vaxjo, Sweden
CH-Aarau-KSA
Aarau, Switzerland
CH-Basel-USB
Basel, Switzerland
CH-Bellinzona-IOSI
Bellinzona, Switzerland
CH-Bern-INSEL
Bern, Switzerland
KS Graubunden
Chur, Switzerland
CH-Geneve (14)-HCUGE
Geneva, Switzerland
Kantonsspital Baselland
Liestal, Switzerland
CH-Luzern-LUKS
Lucerne, Switzerland
CH-St. Gallen-KSSG
Sankt Gallen, Switzerland
CH-Zürich-USZ
Zurich, Switzerland
Baskent University Hospital
Adana, Turkey (Türkiye)
Gazi University Hospital
Ankara, Turkey (Türkiye)
University Hospital Ankara
Ankara, Turkey (Türkiye)
Istanbul University Hospital
Istanbul, Turkey (Türkiye)
Ege University Hospital
Izmir, Turkey (Türkiye)
Erciyes University Hospital
Kayseri, Turkey (Türkiye)
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PMID: 38062124DERIVEDSchmitz 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.
PMID: 35123422DERIVEDSonneveld 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.
PMID: 34520219DERIVEDCavo 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.
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PMID: 30561775DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter Sonneveld, Prof.
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 24, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2020
Study Completion
January 1, 2025
Last Updated
January 6, 2026
Record last verified: 2025-10