sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 95 MM


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


return to top

News


HO95 news

Go to the EMN website: (http://www.mm-sen.net/)

 

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.

 

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:

- 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



Summary

HOVON 95 MM = EMN02
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


Status

closed


Members

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



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

1500


Current number of patients

0


Date of activation

21-Jan-2011


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_METC: 30NOV12
NL_CA: 10JUL12

Amendmend 4
NL_METC: 16APR13
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



Registration

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 http://www.mm-sen.net. 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 - Centrum)


Co-Investigator(s)

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)
Dr. S. Carvalho (Instituto Português de Oncol. Lisboa)
Dr. C. Driessen (Kantonsspital St. Gallen)
Mr. Prof. P. Gimsing (Rigshospitalet Copenhagen)
Prof. Dr. R. Hajek (University Hospital BRNO)
Prof. Dr. H. Ludwig (Wilhelminenspital)
Dr. U.H Mellqvist (Sahlgrenska sjukhuset)
Prof. A. Palumbo (Osp. G. Battista Le Molinette -V.Genova)
Dr. L. Plawny (Centre Hospitalier de Luxembourg)
Prof. Dr. A. Spencer (Alfred Health)
Dr. H. Steingrímsdóttir (Landspitali University Hospital)
Dr. E. Terpos (Regional General Hospital Alexandra)
Dhr. A. Waage (St. Olav univ Hospital)
Dhr. Dr. K.L. Wu (ZNA Stuivenberg)


Statistician(s)

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


Trial Manager(s)

Mw. P.B. Cornelisse (Erasmus MC - Daniel)


Central Data Manager(s)

Dr. F. Leotta (EMN)


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. J. Kloezeman (Erasmus MC - Daniel)
Mw. T. van de Klundert (Erasmus MC - Daniel)


Other functions

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


Central data management

EMN Data Center, Turin
(emntrialistgroup@yahoo.com)


5. Participating sites



Site
Included patients *
AT-Linz-A.ö.k Elisabethinen Linz
0
AT-Salzburg-SALK Salzburg
0
AT-Vienna-Wilhelminenspital
0
AU-Brisbane-Princess Alexandra
0
AU-Canberra-Canberra Hospital
0
AU-Melbourne-Alfred Health
0
AU-Sydney-Concord Repatriation General Hospital
0
AU-Sydney-Nepean Hospital
0
AU-Sydney-Prince of Wales Hospital
0
AU-Sydney-St George Hospital
0
Show 180 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


 Protocol



return to top