Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Major trial tests best drug combo for blood cancer control

NCT ID NCT01208766

Disease control Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different drug combinations in 1,503 adults aged 18-65 with newly diagnosed multiple myeloma. The goal was to see which approach—standard drugs or high-dose chemo with stem cell transplant—works better to delay the cancer's return. Patients received maintenance therapy until relapse, meaning the focus is on long-term disease control, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,503 people

The number who actually took part.

Started

Jan 2011

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • A.O. Bianchi Melacrino Morelli_Ops Riunti

    Reggio Calabria, Italy

  • A.O.R.N. San G. Moscati

    Avellino, Italy

  • AO Cardinale G. Panico

    Tricase, Italy

  • AO Ospedali Riunti Marche Nord

    Pesaro, Italy

  • AOU Ospedali Riuniti

    Trieste, Italy

  • AOU S.Maria della Misericordia

    Udine, Italy

  • AOU Senese Policlinico S. Maria alle Scotte

    Siena, Italy

  • AOU Umberto I-Clinica di Ematologica

    Ancona, Italy

  • ASUR Regione Marche

    Marche, Italy

  • AT-Vienna-HANUSCH

    Vienna, Austria

  • 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

  • AZ Turnhout

    Turnhout, Belgium

  • Azienda Osp S. Andrea

    Roma, Italy

  • Azienda Ospedaliera Papardo

    Messina, Italy

  • Azienda Ospedaliera S. Maria Nuova

    Reggio Emilia, Italy

  • Azienda Ospedaliera S. Maria della Misericordia

    Perugia, 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

  • BE-Antwerpen Edegem-UZA

    Antwerp, Belgium

  • BE-Antwerpen-ZNASTUIVENBERG

    Antwerp, Belgium

  • BE-Haine-Saint-Paul-JOLIMONT

    Haine-Saint-Paul, Belgium

  • BE-Liege-CHRCITADELLE

    Liège, Belgium

  • BE-Mons-AMBROISE

    Mons, Belgium

  • BE-Roeselare-AZDELTA

    Roeselare, Belgium

  • Baerum hospital

    Sandvika, Norway

  • Baskent University Hospital

    Adana, Turkey (Türkiye)

  • CH Wapi

    Tournai, Belgium

  • CH-Aarau-KSA

    Aarau, Switzerland

  • CH-Basel-USB

    Basel, Switzerland

  • CH-Bellinzona-IOSI

    Bellinzona, Switzerland

  • CH-Bern-INSEL

    Bern, Switzerland

  • CH-Geneve (14)-HCUGE

    Geneva, Switzerland

  • CH-Luzern-LUKS

    Lucerne, Switzerland

  • CH-St. Gallen-KSSG

    Sankt Gallen, Switzerland

  • CH-Zürich-USZ

    Zurich, Switzerland

  • CHR Saint Joseph

    Mons, Belgium

  • CHU Tivoli

    La Louvière, Belgium

  • CZ-Brno-UHBRNO

    Brno, Czechia

  • CZ-Olomouc-FNOL

    Olomouc, Czechia

  • CZ-Ostrava-Poruba-FNO

    Ostrava, Czechia

  • Centrallasareltet Vaxjo

    Vaxjo, Sweden

  • 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

  • Ege University Hospital

    Izmir, Turkey (Türkiye)

  • Erciyes University Hospital

    Kayseri, Turkey (Türkiye)

  • Eskilstuna Malar Hospital

    Eskilstuna, Sweden

  • FI-Turku-TYKS

    Turku, Finland

  • Falun Hospital

    Falun, Sweden

  • Fondazione Maugeri

    Pavia, Italy

  • Forde Central Hosiptal

    Førde, Norway

  • Francisco Gentil

    Lisbon, Portugal

  • GR-Athens-ALEXANDRA

    Athens, Greece

  • Gazi University Hospital

    Ankara, Turkey (Türkiye)

  • Giaccone di Palermo

    Palermo, Italy

  • Hallands Hospital Halmstad

    Halmstad, Sweden

  • Harstad University Hospital

    Harstad, Norway

  • Haukeland University Hospital

    Bergen, Norway

  • Helse Sunnmore

    Ålesund, Norway

  • Helsingborg General Hospital

    Helsingborg, Sweden

  • IRST

    Meldola, Italy

  • Inst Regina elena-SC Ema IFO

    Roma, Italy

  • Inst per la Ricerca e la Cura del Cancro Di

    Candiolo, Italy

  • Instituto di Ematologia e Oncologia Medica

    Bologna, Italy

  • Istanbul University Hospital

    Istanbul, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Istituto Nazionale dei Tumori-Ema

    Milan, Italy

  • KS Graubunden

    Chur, Switzerland

  • Kantonsspital Baselland

    Liestal, Switzerland

  • Kralove-University Hospital Hradec Kralove

    Hradec, Czechia

  • Krankenhaus d.Elisabethinen

    Linz, Austria

  • LU-Luxembourg-CHL

    Luxembourg, Luxembourg

  • Landeskrankenhaus Salzburg

    Salzburg, Austria

  • Levanger Hospital

    Levanger, Norway

  • Lidkoping Hospital

    Lidköping, Sweden

  • 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-Den Bosch-JBZ

    's-Hertogenbosch, Netherlands

  • NL-Den Haag-HAGA

    The Hague, Netherlands

  • NL-Deventer-DZ

    Deventer, Netherlands

  • NL-Dirksland-VANWEELBETHESDA

    Dirksland, Netherlands

  • NL-Doetinchem-SLINGELAND

    Doetinchem, Netherlands

  • NL-Dordrecht-ASZ

    Dordrecht, 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-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

  • NO-Lørenskog-AKERSHUS

    Lørenskog, Norway

  • NO-Oslo-OSLOUH

    Oslo, Norway

  • NO-Stavanger-HELSESTAVANGER

    Stavanger, Norway

  • NO-Tromsø-NORTHNOORWEGEN

    Tromsø, Norway

  • NO-Trondheim-STOLAV

    Trondheim, Norway

  • Nij Smellinghe

    Drachten, Netherlands

  • Oaspedali Riuniti_Div di Ematologia

    Bergamo, Italy

  • Orebro University Hospital

    Örebro, Sweden

  • Osp Dell Angelo

    Mestre, Italy

  • Osp S Maria delle Croci_Ema

    Ravenna, Italy

  • Osp San Luigi Gonzaga-Pat med

    Orbassano, Italy

  • Osp. san Camillo Forlanini

    Roma, Italy

  • Ospedale A. Manzoni

    Lecco, Italy

  • Ospedale C. e G. Mazzoni-Ematologia

    Ascoli Piceno, Italy

  • Ospedale Cardarelli-Sezione di Ematologia TERE

    Naples, Italy

  • Ospedale Cardarelli-ematologia e Trapianto di Midollo Osseo

    Naples, Italy

  • Ospedale Ferrarotto-Ema

    Catania, Italy

  • Ospedale Generale Regionale_Div di Ema e Centro

    Bolzano, Italy

  • Ospedale Infermi

    Rimini, Italy

  • Ospedale Niguarda Cà Grande

    Milan, Italy

  • Ospedale Oncologica Regionale

    Rionero in Vulture, Italy

  • Ospedale S Eugenio_Ema

    Roma, Italy

  • Ospedale San Francesco

    Nuoro, Italy

  • Ospedale San Giovanni Addolorata

    Roma, Italy

  • OspedaleCivico S Croce e carle

    Cuneo, Italy

  • Ospedali Riuniti di Foggia

    Foggia, Italy

  • Ospedaliera di Pavona_Ematologia e

    Padova, Italy

  • PO SS Ann e S.G. Moscati-Ema

    Taranto, Italy

  • Policlinico Gaetano Martino

    Messina, Italy

  • Policlinico San Matteo

    Pavia, Italy

  • Policlinico di Bari

    Bari, Italy

  • Policlinico- servizio di Ematologia

    Modena, Italy

  • Pres Osp Di Summa

    Brindisi, Italy

  • Presidio Osp R. Binaghi

    Cagliari, Italy

  • Presidio Osp dello Spirito Santo

    Pescara, Italy

  • Presidio ospedaliero dell'annunziata

    Cosenza, Italy

  • Prince of Wales Hospital

    Sydney, Australia

  • RHMS

    Saint-Ghislain, Belgium

  • Ryhov Hospital

    Jönköping, Sweden

  • SE-Boras-SASBORAS

    Borås, Sweden

  • SE-Linköping-REGIONOSTERGOTLAND

    Linköping, Sweden

  • SE-Luleå-SUNDERBY

    Luleå, Sweden

  • SE-Lund-SUH

    Lund, Sweden

  • SE-Stockholm-KAROLINSKAHUDDINGE

    Stockholm, Sweden

  • SE-Uppsala-UPPSALAUH

    Uppsala, Sweden

  • SS Antonio e Biogio

    Alessandria, Italy

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • San Giovanni Battista Le Molinette-Ema 1

    Torino, Italy

  • San Giovanni Battista Le Molinette-Ema 2

    Torino, Italy

  • Spedali Civili_U.O.Ematologia

    Brescia, Italy

  • St George Hospital

    Sydney, Australia

  • St. Istvan and St. Laszlo Korhaz Hospital

    Budapest, Hungary

  • St. Maria_Oncoematologia

    Terni, Italy

  • Sundsvall Hospital

    Sundsvall, Sweden

  • Szeged University Hospital

    Szeged, Hungary

  • Sørlandet Hospital

    Kristiansand, Norway

  • UC Biomedico_Divisione di Ematologia

    Roma, Italy

  • Uddevall Hospital

    Uddevalla, Sweden

  • Umea University Hospital

    Umeå, Sweden

  • Universita Federico II-Ema

    Naples, Italy

  • Universita La Sapienza_Ospedale Umberto I

    Roma, Italy

  • University Hospital Ankara

    Ankara, Turkey (Türkiye)

  • University Hospital Kralovske Vinohrady

    Prague, Czechia

  • University Hospital Plzen

    Pilsen, Czechia

  • Università Amedeo Avogrado-Ospedale Maggiore

    Novara, Italy

  • Università La Sapienza Polo Pontino

    Latina, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.