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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bortezomib, Melphalan, Prednisone (VMP)
1 or 2 cycle(s) HDM (High Dose Melphalan)
2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)
Sponsored by
Stichting Hemato-Oncologie voor Volwassenen Nederland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma (Kahler's disease)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

No Intervention

Experimental

Arm Label

R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)

R1: 1 (2) cycle(s) HDM

R2: none

R2: 2 cycles of VRD

Arm Description

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.

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.

No consolidation, patients will continue to Lenalidomide maintenance.

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.

Outcomes

Primary Outcome Measures

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).
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
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

Secondary Outcome Measures

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.
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.
Toxicity
Toxicity
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.

Full Information

First Posted
September 23, 2010
Last Updated
August 17, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT01208766
Brief Title
Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Acronym
HO95
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2011 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma (Kahler's disease)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
R1: 1 (2) cycle(s) HDM
Arm Type
Experimental
Arm Description
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.
Arm Title
R2: none
Arm Type
No Intervention
Arm Description
No consolidation, patients will continue to Lenalidomide maintenance.
Arm Title
R2: 2 cycles of VRD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib, Melphalan, Prednisone (VMP)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
1 or 2 cycle(s) HDM (High Dose Melphalan)
Intervention Description
- 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.
Intervention Type
Drug
Intervention Name(s)
2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)
Intervention Description
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
Primary Outcome Measure Information:
Title
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
Description
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)
Title
For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
Description
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)
Title
For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
Description
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)
Secondary Outcome Measure Information:
Title
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.
Description
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)
Title
Toxicity
Description
Toxicity
Time Frame
End of trial (last patient last visit)
Title
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
Description
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)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35123422
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.
Results Reference
derived
PubMed Identifier
34520219
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.
Results Reference
derived
PubMed Identifier
32359506
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. Erratum In: Lancet Haematol. 2020 Jun;7(6):e443. Lancet Haematol. 2020 Nov;7(11):e785.
Results Reference
derived
PubMed Identifier
30561775
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.
Results Reference
derived
Links:
URL
http://www.hovon.nl
Description
Hovon website

Learn more about this trial

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

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