HOVON HO87 MM

Closed

Main info

Identifier:
HO87 MM
Sponsor:
HOVON
Working group party:
Myeloma
Age:
> 65
Stage:
1st Line
Echelon:
Level D
Included patients:
668
(of 668)
Active sites:
109
(of 49)
Title:

Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide.

Timeline

Scheduled
Actual
2008
04 Jan
Opportunity
2008
20 Oct
EC Approval
2008
01 Dec
FPI
2008
01 Dec
First Site
2009
26 Jan
First Site
2009
26 Jan
Activated
2009
12 Mar
FPI
2012
19 Oct
ClosedForInclusionActualStart
2014
15 Nov
Endpoint Analysis
2021
12 Feb
CloseoutInProgressLastPtOutScheduledStart

News

05 August 2019: Protocol version 04 JUN 2019 is available
19 October 2012: The HOVON 87 MM/NMSG 18 study is closed for entry of new patients, because it has reached its target of 668 patients.

New downloads:
14 November 2018: New version of SAE form and SPM form are available
31 October 2018: New version of WMO is available
29 March 2018: CRF version (March 29, 2018) is available with new address in header.
06 June 2013: 'Statement of expenses form' (new roomnumber) available under heading 'news'.
20 September 2012: New version of flowsheet is available.
12 October 2011: New lab manual - NL is available.

Flow

Flow

Details

Phase:
Prospective Phase III study
Monitoring Type:
Not any more
Objectives:

Primary endpoint

  • Progression free survival, defined as time from registration to progression or death from any cause
  • Response rate defined as sCR, CR or VGPR

Secondary endpoints

  • Overall response rate defined as sCR, CR, VGPR or PR
  • Overall survival, measured from time of registration
  • Quality of response during maintenance, measured as improvement of response (from start maintenance till progression)
  • Time to maximum response, defined as time from registration to maximum response
  • Time to death from relapse/progression (after initial response), measured from time of first relapse/progression
  • Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC), version 3.0
  • Quality of life as defined by the EORTC QLQ-C30 definitions.

Eligibility

Inclusion Criteria:
  • Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
  • Age > 65 years or patients ≤ 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation
  • WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients ≥ 75 years (see appendix E)
  • Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy (see appendix A for definitions)
  • Written informed consent
Exclusion Criteria:
  • Non-secretory MM
  • Known hypersensitivity to thalidomide
  • Systemic AL amyloidosis
  • Polyneuropathy, grade 2 or higher
  • Severe cardiac dysfunction (NYHA classification II-IV, appendix F)
  • Severe pulmonary dysfunction
  • Significant hepatic dysfunction (total bilirubin ≥ 30 μmol/l or transaminases ≥ 3 times normal level), unless related to myeloma
  • Creatinine clearance <30 ml/min
  • Patients with active, uncontrolled infections
  • Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed.
  • Patients known to be HIV-positive
  • History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
  • Not able and/or not willing to use adequate contraception
  • Pregnancy

Registration Details

Eligible patients should be randomized before start of treatment. Patients need to be registered at the HOVON Data Center of the Erasmus MC Rotterdam via the Internet via TOP (Trial Online Process; https://www.hdc.hovon.nl/top) or by phone call: +31.10.7041560 or fax +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET. A logon to TOP can be requested at the
HOVON Data Center for participants.
The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Sex
  • Date of birth
  • Date written informed consent
  • ISS stage
  • Will patient participate in the quality of life study
  • ‘Risk Management Program’ discussed with patient
  • Approval for blood storage for scientific research
  • Approval for bone marrow storage for scientific research
  • Eligibility criteria

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
109 results
Order by
Accrual rate
Activation date
NL-Dordrecht-ASZ
25
12 Mar 2009
SE-Lund-SUH
24
29 Apr 2010
NO-Trondheim-STOLAV
20
11 Sep 2009
NL-Groningen-MARTINI
19
10 Sep 2009
NL-Hilversum-TERGOOI
18
15 Jul 2009
NL-Goes-ADRZ
17
29 Jun 2009
NL-Amersfoort-MEANDERMC
17
15 Jun 2009
NL-Zwolle-ISALA
17
12 Mar 2009
NL-Den Bosch-JBZ
15
15 Jun 2009
NL-Gouda-GROENEHART
15
27 May 2009
NL-Alkmaar-NWZ
15
11 Jun 2009
NL-Zaandam-ZAANSMC
14
27 Jan 2010
NL-Rotterdam-MAASSTADZIEKENHUIS
14
15 Jul 2009
SE-Goteborg-SAHLGRENSKA
14
27 Apr 2010
DK-Copenhagen-RIGSHOSPITALET
14
11 Jan 2010
NL-Delft-RDGG
14
27 Apr 2009
NL-Tilburg-ETZ
13
26 Jun 2009
NL-Arnhem-RIJNSTATE
13
09 Jun 2009
NL-Hoofddorp-SPAARNEGASTHUIS
11
12 Mar 2009
NL-Ede-ZGV
11
17 Dec 2009
NL-Amsterdam-VUMC
11
12 Mar 2009
NL-Maastricht-MUMC
10
28 May 2009
NL-Nieuwegein-ANTONIUS
10
03 Apr 2009
DK-Vejle-VEJLESYGEHUS
10
26 Jan 2010
NL-Sneek-ANTONIUSSNEEK
10
10 Apr 2009
NL-Dirksland-VANWEELBETHESDA
10
07 May 2009
NL-Roosendaal-BRAVIS
9
16 Feb 2010
NL-Den Haag-HAGA
9
27 Mar 2009
NL-Schiedam-FRANCISCUSVLIETLAND
9
10 Sep 2009
SE-Stockholm-KAROLINSKASOLNA
9
11 Mar 2011
NL-Venlo-VIECURI
9
21 Jul 2009
NO-Forde-HELSEFORDE
8
27 Nov 2009
NL-Apeldoorn-GELREAPELDOORN
8
27 Mar 2009
NL-Utrecht-UMCUTRECHT
8
24 Jul 2009
NL-Breda-AMPHIA
7
22 May 2009
SE-Luleå-SUNDERBY
7
26 May 2010
NL-Winterswijk-SKBWINTERSWIJK
7
26 Jun 2009
SE-Linköping-REGIONOSTERGOTLAND
7
11 Oct 2010
NL-Eindhoven-MAXIMAMC
7
15 Dec 2009
NL-Heerlen-ATRIUMMC
7
27 Jun 2009
NL-Sittard-Geleen-ZUYDERLAND
7
22 May 2009
NL-Enschede-MST
7
02 Nov 2009
NO-Stavanger-HELSESTAVANGER
7
27 Nov 2009
NL-Groningen-UMCG
6
27 May 2009
NL-Delfzijl-OMMELANDERDELFZIJL
6
22 May 2009
NL-Hengelo-ZGTHENGELO
6
22 Jul 2009
NL-Amsterdam-SLOTERVAART
6
12 Mar 2009
NO-Oslo-ULLEVAL
5
07 Oct 2010
SE-Boras-SASBORAS
5
27 Apr 2010
NL-Hoogeveen-TRENTBETHESDA
5
12 Mar 2009
NL-Roermond-LZR
5
30 Nov 2009
NL-Helmond-ELKERLIEK
5
28 May 2010
NL-Amstelveen-AMSTELLAND
5
13 Jul 2009
NL-Nijmegen-RADBOUDUMC
5
17 Apr 2009
NL-Rotterdam-ERASMUSMC
5
03 Apr 2009
NL-Rotterdam-IKAZIA
5
07 Dec 2009
NL-Den Haag-HMCBRONOVO
4
10 Aug 2009
SE-Örebro-OREBROUH
4
21 May 2010
NL-Uden-BERNHOVEN
4
10 Apr 2012
SE-Uddevalla-VGREGION
4
27 Aug 2010
NL-Leeuwarden-MCL
4
12 Jun 2009
NL-Rotterdam-EMCDANIEL
4
23 Apr 2009
NL-Hoorn-DIJKLANDERHOORN
3
16 Sep 2009
NL-Deventer-DZ
3
23 Mar 2009
NL-Amsterdam-OLVG
3
11 Jan 2010
DK-Odense-OUH
3
13 Jul 2011
NL-Leiden-LUMC
3
09 Jun 2009
NL-Woerden-ANTONIUSWOERDEN
3
14 Dec 2010
NL-Den Haag-HMCWESTEINDE
3
14 May 2009
NO-Levanger-HELSENORD
3
09 Apr 2010
NL-Gorinchem-BEATRIX
3
27 Apr 2010
NL-Zutphen-GELREZUTPHEN
3
11 Sep 2009
SE-Stockholm-KAROLINSKAHUDDINGE
3
06 Sep 2011
BE-Antwerpen-ZNASTUIVENBERG
3
10 Feb 2010
NL-Beverwijk-RKZ
3
21 Jan 2010
NL-Amsterdam-AMC
3
12 Mar 2009
SE-Umeå-VASTERBOTTEN
2
14 Jun 2010
NL-Capelle a/d IJssel-YSL
2
10 Sep 2009
NL-Drachten-NIJSMELLINGHE
2
21 Jan 2010
NL-Almelo-ZGTALMELO
2
09 Apr 2009
NL-Terneuzen-ZORGSAAM
2
01 Apr 2010
DK-Herlev-HERLEV
2
23 Dec 2010
NO-Bergen-HELSEBERGEN
2
22 Mar 2010
NO-Tromsø-NORTHNOORWEGEN
1
10 Aug 2010
NL-Rotterdam-SFG
1
28 Apr 2009
NL-Doetinchem-SLINGELAND
1
09 Apr 2010
NL-Amsterdam-SLAZLUCAS
1
09 Apr 2009
NL-Heerenveen-TJONGERSCHANS
1
03 Aug 2011
NL-Leidschendam-HMCANTONIUSHOVE
1
14 Jun 2009
SE-Falun-REGIONDALARNA
21 May 2010
SE-Sundsvall-RVN
02 Jun 2010
BE-Antwerpen-ZNAMIDDELHEIM
28 Apr 2010
NL-Meppel-ISALADIACONESSEN
NO-Oslo-DIAKONSYK
19 May 2010
NO-Bodo-NORDLANDS
NO-Fredrikstad-OSTFOLD
NO-Honefoss-RINGERIKE
23 Dec 2010
NO-Kristiansand-SORLANDET
08 Apr 2010
NO-Harstad-UNNHARSTAD
09 Apr 2010
NL-Utrecht-DIAKONESSENUTRECHT
NL-Almere-FLEVOZIEKENHUIS
01 Sep 2009
NL-Purmerend-DIJKLANDERPURMEREND
08 Jun 2009
NL-Harderwijk-STJANSDALHARDERWIJK
30 Mar 2012
NL-Emmen-SCHEPER
NL-Assen-WZA
29 May 2009
NL-Geldrop-STANNA
28 Sep 2010
NL-Lelystad-STJANSDALLELYSTAD
14 Oct 2010
NL-Tiel-RIVIERENLAND
NO-Alesund-HELSEMR
30 Nov 2009
= Active hospitals
= Inactive hospitals

Participating Parties

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