Corona Virus





Wat betreft HOVON:

Het HOVON Data Center (HDC) en dus ook de HOVON Safety desk blijft onveranderd operationeel om de veiligheid van de patiënten in een HOVON studie te waarborgen.

De levering van studiemedicatie wordt nauwlettend opgevolgd en indien nodig zal tijdig hierover bericht worden.

Centrale lab faciliteiten zijn onveranderd operationeel. Vooralsnog is het mogelijk om patiënten in de HOVON studies te includeren.


Wat betreft deelnemende site:

Indien jullie nav COVID-19 situatie de inclusie voor een studie tijdelijk stopzetten graag het HDC per email hierover informeren (mail naar

Verder, indien er per protocol bepaalde studie visites/handelingen niet (kunnen) plaatsvinden nav COVID-19 situatie graag documenteren in de patiënten file.



Gegeven de situatie rondom Corona virus zijn het HOVON Centraal Bureau (HCB) en het HOVON Data Center (HDC) tijdelijk telefonisch niet bereikbaar.

Graag alle (urgente) vragen via email, deze zullen zsm door het team opgepakt en verwerkt worden. Indien terugbellen noodzakelijk is, graag dit aangeven in de email. Wij hopen op jullie begrip voor deze situatie.

Voor studie specifieke vragen kun je contact opnemen met de trial manager van de studie of via het algemene HDC email adres ( – voeg HOVON studie nr toe).



Met vriendelijke groet, Marleen Breems (HOVON General Director) en Bianca Backx (manager HDC)

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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 95 MM

1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms

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HO95 news

For data management go to the EMN website: (


Sampling (at relapse/progression to central lab) IMPORTANT: it is not possible to ship material on a Friday, Saturday or Sunday. If your hospital routinely has multiple myeloma patient appointments for obtaining clinical samples on these days, please inform the PI and please change the planning. Seeing patients for MM biomaterial sampling on a Friday or on the weekend is in direct conflict with participating in a clinical trial such as this one.


The study has been closed for inclusion on 15APR14, many thanks for your precious collaboration to make this into a highly successfull study! Of course patients included can still receive maintenance treatment.


AM8 (protocol version 7 dd 04DEC2019) has been approved in the Netherlands. Maintenance therapy until progression; data collection during 10 years instead of 7 years. 

AM5 (protocol version 6 dd 06MAY14) has been approved. Change in treatment schedule Lenalidomide during maintenance from 28 days to 21 days followed by 7 days rest. Further information can be found in the summery of changes form.

AM4 (protocol version 5 dd 15JAN13) has been approved. The Lenalidomide doses 2.5mg and 7.5mg has been deleted from the protocol.

AM3 has been approved, the main changes were 4VCD cycles and Velcade s.c. Please find more information in the summary of changes documents.

AM2 has been approved, this concerns the new packaging of Lenalidomide. The new batch will not have vials with capsules, but has blisters with separately packed capsules in a press-through sheet.

AM1 concerned the addition of the Belgium site ZNA Stuivenberg and the integrations of adverse events of lenalidomide including the risk of 2nd cancer


Updated documents:

- 28MAY2020: Updated CRF instructions

- 14JAN2020: Updated SAE form with new fax number

- 27MAR2017: Updated Lenalidomide accountability form, to add "Returned by patient" as option, so that this part of the accountability is not forgotten.

- 14DEC15: Updated Pharmacy information letter to reflect usage of IDOS + uploade IDOS instructions below other documents

- 18NOV15: Renewed drug order form for Lenalidomide

- 29SEP14: Deletion of subject enrollement list to make room for QoL declaration form (please note, this can only be used by Dutch sites.

- 30JUL14: Deletion of Registrate Enroll and Randomization CRF's_26NOV12, replacement by separate Randomization 1 and Randomization 2 CRF

- 16JUL14: New protocol (version 6) + summery of changes, updated portfolio regarding EC and CA approval for the Netherlands

- 15MAY14: New Statement of expenses form for Dutch sites for QoL

- 14MAY14: New Dutch WMO insurance (enddate of insurance changed to 2018)

- 08APR14: New FAQ sheet, correctie versie 20MAR14

- 11NOV13: New Pharmacy information letter dated 11NOV13

- 21OCT13: New FAQ sheet

- 19JUN13: New Pharmacy information letter dated 19JUN13

- 03SEP13: New portfolios created for BE (site documents, EC and CA portfolio)

- 11JUN13: New Insurance policy BE (valid util 31DEC13)

- 05FEB13: New Pharmacy information letter dated 05FEB13

- 22JAN13: New Registrate Enroll and Randomization CRFs_26NOV12.pdf

- 07DEC12: New documents regarding AM3

   - Protocol

   - Protocol amendment(s)

   - Patient Information & IC form (NL)

   - Patient Information & IC form (EN)

   - PI & ICF amendment(s)

   - CCMO response

   - MEC approval

   - Signature page of protocol

   - HO95 ICF template asymptomatic patients nl v2 13jun12 cc

   - HO95 ICF asymptomatic patients summary of changes am3 dd 20jun12

   - HO95 ICF template extra sampling nl v1 13jun12

   - EMN02 HO95 ICF alloSCT substudy v2 dd 25jun12 cc

   - HO95 ICF template pet scan substudy nl v1 13jun12

   - HO95 Flowchart_12DEC12

- 28OCT12: SAE form

- 16OCT12: New FAQ sheet

- 16JUL12: CRF instructions

- 19JUN12: SAE instuctions

- 29MAY12: New pharmacy information letter (includes also the option to order Lenalidomide per quarter of the year - was previously only accepted for Bortezomib)

- 29MAR12: 'onderzoeksverklaring' to be used for Dutch sites that did not perform their local submission yet

- 16MAR12: New declaration form of expenses (previous version was lacking contact information)

- 01MAR12: New pharmacy information letter (reflects the adjusted Lenalidomide study medication procedure)

- 16FEB12: EC Approval (portfolio) with AM2 approval

- 25NOV11: EMN02 HO95 eCRF printscreen versions_19AUG11.pdf

- 25NOV11: New version of EMN02 HO95_Registrate, Enroll and Randomization CRFs_25OCT11.pdf

 - 27JUL11: HO95_creation of subaccounts_07JUL11.pdf (new)
- 27JUL11: EMN02 HO95 eCRF printscreen versions_13JUL11.pdf (new)
- 27JUL11: New version of EMN02 HO95_Registrate, Enroll and Randomization CRFs_07JUL11_clean version.pdf (replaces the one dated 28APR11)
- 16JUN11: New Verpleegkundig protocol dated 16JUN11 (replaces the one dated 28APR11)
- 15JUN11: New Pharmacy information letter dated 07JUN11 (replaces the one dated 19APR11)  


1. Overview


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




Participating groups: HOVON, GIMEMA, NMSG, DSMSG, CEMSG, CMG

Study details

Type of study

Prospective randomized Phase III study

Echelon level

Level D

Echelon level specification

For HDM treatment please make collaboration agreements with level A or B site.

Type of monitoring for this study

Site evaluation visits

Target number of patients


Current number of patients


Date of activation


Approved by

NL_METC (2010-122): 04NOV10
NL_CA (NL31466.078.10): 06APR10
NL_CKS (2010-4798): 02SEP10

BE_METC (3629):08SEP10
BE_CA: 27JUL10

Change history / amendement

Amendmend 3
NL_CA: 10JUL12

Amendmend 4
NL_CA: 28MAR13

Study objectives

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

2. Patient 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 Mprotein > 10 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy;), 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) (see appendix D);
Negative pregnancy test at inclusion if applicable;
Written informed consent.

Randomization 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 10^6 CD34+ cells/kg (or according to national guidelines).

Randomization 2
Bilirubin and transaminases < 2.5 times the upper limit of normal values;
ANC >= 0.5 x 10^9/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, see appendix E);
Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), 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.

Randomization 1
Severe pulmonary, neurologic, or psychiatric disease;
CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;
Allogeneic Stem Cell Transplantation (Allo SCT) planned;
Progressive disease.

Randomization 2
Progressive disease;
Neuropathy, except CTCAE grade 1;
CTCAE grade 3-4 polyneuropathy during Bortezomib treatment.

3. Registration (& randomization) of patients


Institution name
Name of responsible investigator
Date of birth
Date of informed consent
Date of sample shipment (optional)
Date of diagnosis of multiple myeloma
Serum B2-microglobulin
Serum albumin
Eligibility criteria

Registered patients
(Last update: 15APR14)

AT-Linz-A.ö.k Elisabethinen-Hem | 4
AT-Salzburg-SALK-3rdMed Onco | 2
AT-Vienna-Wilhelminen-HemOnc | 15
AU-Brisbane-Pr Alexandra-Hema | 5
AU-Canbe-Canberra Hospita-Hema | 4
AU-Melbourn-Alfred Health-Hema | 5
AU-Sydney-Nepean Hospital-Hema | 3
BE-Antwerpen-Middelheim-Hema | 2
BE-Antwerpen-Stuivenberg-Hema | 13
BE-Haine-Saint--Jolimont-ServH | 2
BE-Liege-Citadelle-ServHem | 5
BE-Tournai-Chwapi-HemOnc | 1
BE-Turnho-AZ St Elisabeth-Hema | 6
CH-Aarau-Kantonsspital-Onk | 3
CH-Basel-UH-Hema | 3
CH-Bellinzona-IOSI-Hema | 3
CH-Bern-Inselspital-Onc | 5
CH-Chur-KS Graubünden-IntMed | 2
CH-Geneve (-Cantonal Univ-Hema | 1
CH-Liestal-KS Baselland-Onco | 3
CH-Luzern-Kantonsspital-Hema | 8
CH-St. Gall-Kantonsspital-Hema | 11
CH-Thun-STSAG-Onco | 1
CH-Zürich-Uv spital-Hema | 2
CZ-Brno-UH-HemaOnco | 21
CZ-Hradec -Hradec Kralove-hema | 23
CZ-Olomouc-Olomouc-Int | 13
CZ-Ostrava-Poruba-Ostrava-Hema | 13
CZ-Plzen-Plzen-Hema | 6
CZ-Prague 2-Praze-Hema | 4
DK-Aalborg-Sygehus-Hema | 9
DK-Aarhus C-Aarhus UH-Hema | 17
DK-Copenhagen-Rigshosp-Hema | 11
DK-Herlev-Herlev-Hema | 8
DK-Odense-Odense Hospital-Hema | 3
DK-Roskilde-Sygenhus-Hema | 6
GR-Athens-Alexandra-IntMed | 37
IS-Reykjavik-Landspitali-Hema | 2
IT-Alessa-Antonio e Biagio-Ema | 8
IT-Ancona-Umberto I-Ema | 18
IT-Ascoli Piceno-Mazzoni-Ema | 1
IT-Avellino-San G Moscati-Ema | 10
IT-Bari-Policlinico-Onco | 10
IT-Bergamo-Riuniti-Ema | 24
IT-Bologna-Malphigi-Ema Onco | 44
IT-Bolzano-AS Bolzano-Ema | 7
IT-Brescia-Civili-Ema | 21
IT-Brindisi-P O A Perino-Ema | 2
IT-Cagliari-P O Binagli-Ema | 8
IT-Candiolo-IRCC-Ema | 6
IT-Catania-Ferrarotto-Ema | 32
IT-Civitanova -AZUR Zona 8-Med | 1
IT-Cosenza CS-Annunziata-Ema | 10
IT-Cuneo-Croce e Carle-Ema | 19
IT-Foggia-Riuniti-Ema | 4
IT-Gallara-Antonio Abate-Oncoe | 1
IT-Genova-Martino-ClinEma | 7
IT-Genova-Martino-EmaI | 14
IT-Genova-Martino-UOEmaII | 8
IT-Latina-UH Polo Pontino-Ema | 3
IT-Lecco-Manzoni-Onco | 3
IT-Meldola-ISR-Onco | 7
IT-Messina-PU s Martino-Ema | 7
IT-Mestre-Osp dell'Angelo-Ema | 16
IT-Milano-IRCCS / Ema | 23
IT-Milano-Niguarda-Ema | 11
IT-Modena-Policlinico-Ema | 8
IT-Napoli-Cardarelli-EmaMidOss | 3
IT-Napoli-Federico-Ema | 4
IT-Nuoro-San Francesco-Ema | 11
IT-Padova-UDS-Ema | 17
IT-Palermo-Paolo Giaccone-Ema | 5
IT-Pavia-Maugeri-Ema | 5
IT-Perugia-St Maria-Ema | 18
IT-Pesaro-San Salvatore-Ema | 1
IT-Pescara-S Spirito-Ema | 14
IT-Ravenna-St Maria-Ema | 9
IT-Reggio Cala-Bianchi Morelli- | 19
IT-Reggio Em-S Maria Nuova-Ema | 22
IT-Rimini-Infermi-OncoEma | 6
IT-Rionero in Vultur-IRCCS-Ema | 7
IT-Roma-Regina Elina-Ema | 6
IT-Roma-S Eugenio-Ema | 12
IT-Roma-S Giovanni-Ema | 5
IT-Roma-San Camillo-Ema | 10
IT-Roma-Sant'Andrea-Ema | 2
IT-Roma-Sapienza-Ema | 49
IT-Roma-UC-Ema | 4
IT-Rozzano,Milan-Humanitas-Ema | 9
IT-Siena-Sclavo-Ema | 3
IT-Terni-S Maria-Onco | 17
IT-Torin-Molinette Bramant-Ema | 16
IT-Torino-Mauriziano | 67
IT-Tricase (Lecce)-Panico-Ema | 4
IT-Trieste-Maggiore-Ema | 8
IT-Udine-PU-Ema | 29
LU-Luxembourg-CHL-Hema | 1
NL-Alkmaar-MCAlkmaar-Hema | 7
NL-Amersfoort-Meander-IntGen | 6
NL-Amstelveen-Amstelland-InwGen | 1
NL-Amsterdam-AMC-Hema | 7
NL-Amsterdam-Lucas-InwGen | 5
NL-Amsterdam-OLVG-Hema | 8
NL-Amsterdam-VUMC-Hema | 15
NL-Apeldoorn-Gelre-IntGen | 2
NL-Arnhem-Rijnstate-InwGen | 7
NL-Bergen op Zoom-Lievensberg-I | 1
NL-Beverwijk-RKZ-IntGen | 1
NL-Breda-Amphia, Langend-IntGe | 13
NL-Capelle a/-IJsselland-IntGe | 5
NL-Delft-RdeGraaf-IntGen | 5
NL-Den Bosc-Jeroen Bosch-IntGe | 4
NL-Den Haag-Leyenburg-Hema | 18
NL-Deventer-Deventer ZH-InwGen | 7
NL-Dordr-Schweitzer Dord-IntGe | 15
NL-Drachten-Smellinghe-IntGen | 1
NL-Ede-Gelderse Vallei-IntGen | 6
NL-Eindhoven-Maxima MC-Hema | 4
NL-Enschede-MS Twente-IntGen | 8
NL-Geldrop-Anna-IntGen | 1
NL-Goes-De Ruyter-InwGen | 9
NL-Gorinchem-Beatrix-InwGen | 2
NL-Gouda-Groene Hart-IntGen | 4
NL-Groningen-UMCG-Hema | 6
NL-Haarlem-Kennemer-IntGen | 1
NL-Heerlen-Atrium-IntGen | 6
NL-Helmond-Elkerliek-IntGen | 3
NL-Hilversum-Tergooi-IntGen | 4
NL-Hoofddorp-Spaarne-IntMed | 6
NL-Hoorn-Westfriesgasthuis-IntG | 9
NL-Leiden-LUMC-Hema | 12
NL-Maastricht-AZM-IntGen | 15
NL-Nieuwegein-Antonius Ng-IntGe | 8
NL-Nijmegen-Canisius-InwGen | 11
NL-Nijmegen-Radboud-Hema | 18
NL-Oss-Bernhoven-InwGen | 4
NL-Roermond-Laurentius-InwGen | 3
NL-Roosendaal-Franciscus-IntGe | 4
NL-Rotterdam-EMC Centrum-Hema | 14
NL-Rotterdam-Franciscus-IntGen | 5
NL-Rotterdam-Ikazia-InwGen | 3
NL-Rotterdam-Maasstad-IntGen | 9
NL-Schiedam-Vlietland-IntGen | 6
NL-Tilburg-Elisabeth-IntGen | 11
NL-Utrecht-UMCU-Hema | 9
NL-Venlo-VieCuri-InwGen | 3
NL-Vlissingen-De Ruyter-InwGen | 3
NL-Winterswijk-Beatrix-IntGen | 6
NL-Zaandam-ZaansMC-IntGen | 3
NL-Zwolle-Isala Sophia-IntGen | 11
NO-Alesund-Helse Sunnmore-Hema | 3
NO-Forde-Hosp-Hema | 3
NO-Oslo-Rikshosp-Hema | 6
NO-Rud-Baerum Hospital-IntMed | 5
NO-Stavanger-UH Rogaland-Hema | 3
NO-Tromsø-UH North-Hema | 4
NO-Trondheim-Olav-Hema | 5
PT-Lisboa-Inst Onco-Hema | 5
SE-Boras-Boras-Hema | 3
SE-Falun-Falu-IntMed | 1
SE-Goteborg-Sahlgrenska-Hema | 11
SE-Linköping-UH-Hema | 3
SE-Luleå-Sunderby-Intmed | 4
SE-Lund-Skane-Hema | 22
SE-Örebro-Örebro UH-Hema | 1
SE-Uddevalla-NU-IntMed | 4
SE-Umeå-UH North-Hema | 3
SE-Vaxjo-Vaxjo-IntMed | 1
TR-Adana-Baskent UH-Hema | 5
TR-Ankara-Cebeci-Hema | 41
TR-Ankara-Gazi UH-Hema | 12
TR-Kayseri-Erciyes-Hema | 2

Registration criteria

The following information will be requested:

Patients will be registered at the EMN Data Center by web Investigators who
do not have an account yet should register at this website to obtain an account.

4. Participating parties

Principal Investigator(s)

Prof. Dr. P. Sonneveld (Erasmus MC)


Prof. M. Cavo (Policlinico S. Orsola Malphigi)
Prof. Dr. H. Einsele (Universitätsklinikum Würzburg)
Prof. Dr. H.M. Lokhorst (VUMC)

Coordinating Investigator(s)

Prof. Dr. M. Beksac (Ankara University Hosp. Cebeci Hastanesi)
Prof. M. Boccadoro (AOU San Giovanni Battista Le Molinette)
Dr. S. Carvalho (Instituto Português de Oncol. Lisboa)
Dr. M.A. Dimopoulos (Regional General Hospital Alexandra)
Dr. C. Driessen (Kantonsspital St. Gallen)
Prof. P. Gimsing (Rigshospitalet Copenhagen)
Prof. Dr. R. Hajek (University Hospital Ostrava)
Prof. Dr. H. Ludwig (Wilhelminenspital)
Dr. U.H Mellqvist (Sahlgrenska sjukhuset)
Dr. L. Plawny (Centre Hospitalier de Luxembourg)
Prof. Dr. A. Spencer (The Alfred Hospital)
Dr. H. Steingrímsdóttir (Landspitali University Hospital)
Dr. Mr. A. Waage (St. Olav univ Hospital)
Dhr. Dr. K.L. Wu (ZNA Stuivenberg)
Dr. T. Zander (Kantonsspital Luzern)


Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)

Trial Manager(s)

Mw. H.A. Visser - Wisselaar (Erasmus MC - Daniel)

Central Data Manager(s)

Dr. F. Leotta (EMN)

Monitor - Site Evaluation Visits

Mw M. Jansma (Erasmus MC - Daniel)
Mw. J. Kloezeman (Erasmus MC - Daniel)
Mw. T. van de Klundert (Erasmus MC - Daniel)
Mrs. M. Spaans (Erasmus MC - Daniel)

Other functions

Central Coordinator - Rapid Form - Ms. G. Lupparelli (EMN)
Central Coordinator - Special Investigations - Mw. D. Hofste op Bruinink (Erasmus MC)
Central Coordinator - Special Investigations - Dhr. M. Schoester (Erasmus MC)
Central Coordinator - Special Investigations - Mw. J. Veth (Erasmus MC)
Reviewer - Cytogenetics - Dhr. Dr. A. Buijs (UMC Utrecht)
Reviewer - Cytogenetics - Dhr. D. Olde Weghuis (Medisch Spectrum Twente)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)

Trial manager

H. Visser (

Central data management

EMN Data Center, Turin

Other functions

Please contact monitors at

5. Participating sites

Included patients *
AT-Linz-Ordensklinikum Linz GmbH Elisabethinen
AT-Salzburg-SALK Salzburg
AU-Brisbane-Princess Alexandra
AU-Canberra-Canberra Hospital
AU-Melbourne-The Alfred Hospital
AU-Sydney-Concord Repatriation General Hospital
AU-Sydney-Nepean Hospital
AU-Sydney-Prince of Wales Hospital
AU-Sydney-St George Hospital
Show 178 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos

7. Download documentation / forms


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