HOVON HO123 MM

Gesloten

Main info

Identificatie:
HO123 MM
Sponsor:
HOVON
Working group party:
Myeloma
Age:
>= 75
Stadium:
1st lijn
Echelon:
Level D
Included patients:
240
(of 240)
Active sites:
66
(of 64)
Title:

Feasibility and Efficacy of dose adjusted Melphalan – Prednisone – Bortezomib (MPV) in elderly patients ≥ 75 years of age with newly diagnosed Multiple Myeloma; a non-randomised phase II study

Timeline

Scheduled
Actual
2013
14 nov.
EC Approval
2014
07 jan.
Activated
2014
07 jan.
First Site
2014
04 feb.
FPI
2017
17 mei
ClosedForInclusionActualStart
2019
04 jan.
Opportunity
2019
01 jul.
Endpoint Analysis

News

25 August 2017: Protocol version 7 (9 august 2017) is active

2018: New link to eCRF: https://aleaclinical.com/hovon/dm/

Updated documents:

28-11-2017: New version of SAE report form and pregnancy form (notifications by mail instead of fax)

29-03-2016: New version of the flowsheet is available

15-jan-2016: ICF v6.1 and new insurance certificate are available

28-oct-2015: new 'Statement of Expenses' form is available

14-jul-2015: Protocol version 4 (22jan2015); Patient Information version 5 (18may2015) and Pre-Study Patient Information (15jun2015) are available

12-oct-2015: newsletter 8 is available

23-jan-2015: HOVON 123 MM eCRF and instructions are available

17-jun-2014: new TNT shipment instructions for bone marrow and blood

10-apr-2014: FAQ document is available

18-mar-2014: newsletter 4 & CT-scan shipment information form

20-feb-2014: QoL questionnaires (paper version) are available

11-dec-2013: Statement of Expenses form is available

11-dec-2013: Contactform & ITF labels are available

20-nov-2013: Updated version WMO certificate available

Flow

Flow

Details

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

Primary objective

  • To assess the feasibility, defined as the discontinuation rate, of a dose-adapted MPV scheme in MM patients ≥ 75 years of age

Secondary objectives

  • To assess toxicity
  • To assess efficacy, defined as response rate, PFS and OS
  • To assess time to response
  • To assess the relative dose intensity of MPV
  • To assess the cumulative dose intensity of MPV
  • To assess the predictive value of geriatric assessments, biomarkers reflecting biological age and sarcopenia with respect to discontinuation rate, toxicity and efficacy
  • To assess Quality of Life
  • To analyze the value of polymorphism of genes involved in drug metabolism in predicting bortezomib-induced PNP
  • To assess the prognostic value of risk factors at diagnosis, including β2-microglobulin and chromosomal abnormalities
  • To analyze the prognostic value of myeloma gene expression profiles
  • Cost effectiveness analysis

Eligibility

Inclusion Criteria:
  • Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
  • Age ≥ 75 years
  • WHO performance status 0-3, WHO 4 performance status is allowed when related to MM (see appendix E)
  • Measurable disease as defined by the presence of M-protein in serum or urine and/or abnormal free light chain (FLC) ratio with involved FLC (see appendix A for definitions). (If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation).
  • Patient gives consent for extra bone marrow, blood and skin biopsy sampling
  • Written informed consent.
Exclusion Criteria:
  • Non-secretory MM
  • Systemic Amyloid Light-chain (AL) amyloidosis
  • Polyneuropathy, grade 1 with pain or grade ≥ 2
  • Severe cardiac dysfunction (NYHA classification IV, appendix F)
  • Severe pulmonary dysfunction defined as breathlessness at rest
  • Significant hepatic dysfunction (total bilirubin ≥ 30 μmol/l or transaminases ≥ 3 times normal level), unless related to MM
  • Renal insufficiency requiring dialysis
  • Patients with active, uncontrolled infections
  • Pre-treatment with cytostatic drug, immunomodulatory drugs (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 Human Immunodeficiency Virus (HIV)-positive
  • Active malignancy other than MM requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Patients with plasma cell leukemia

Registration Details

Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:

  • By ALEA; Use goto eCRF button > select the [Patient tab] and click the [Add new patient] button. Complete all items and click the [Submit] button
  • By faxing the completed registration/randomization CRF +31 (0)10 704 1028 Monday through Friday, from 09:00 to 17:00 CET
  • By phone +31 (0)10 704 1560 Monday through Friday, from 09:00 to 17:00 CET

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
  • Specific items patient gives consent for (see ICF)
  • 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
66 results
Order by
Accrual rate
Activation date
NL-Dordrecht-ASZ
17
30 jan. 2014
NL-Leeuwarden-MCL
11
03 mrt. 2014
NL-Amstelveen-AMSTELLAND
11
01 sep. 2014
NL-Den Haag-HAGA
11
10 apr. 2014
NL-Amersfoort-MEANDERMC
11
31 mrt. 2014
NL-Ede-ZGV
10
03 mrt. 2014
NL-Alkmaar-NWZ
10
08 mei 2014
NL-Schiedam-FRANCISCUSVLIETLAND
9
31 mrt. 2014
NL-Zutphen-GELREZUTPHEN
9
06 feb. 2014
NL-Sittard-Geleen-ZUYDERLAND
8
31 mrt. 2014
NL-Gorinchem-BEATRIX
8
04 aug. 2014
NL-Roosendaal-BRAVIS
6
26 mei 2014
NL-Rotterdam-MAASSTADZIEKENHUIS
6
31 jul. 2014
NL-Hoofddorp-SPAARNEGASTHUIS
6
31 mrt. 2014
NL-Venlo-VIECURI
6
10 mrt. 2014
NL-Harderwijk-STJANSDALHARDERWIJK
6
14 apr. 2014
NL-Arnhem-RIJNSTATE
6
26 jan. 2015
NL-Hilversum-TERGOOI
6
28 apr. 2014
NL-Hoogeveen-TRENTBETHESDA
6
01 mei 2014
NL-Gouda-GROENEHART
5
15 apr. 2014
NL-Goes-ADRZ
5
09 mei 2014
NL-Den Bosch-JBZ
5
23 dec. 2014
NL-Zaandam-ZAANSMC
5
19 mrt. 2015
NL-Apeldoorn-GELREAPELDOORN
4
28 mei 2015
NL-Deventer-DZ
4
30 jun. 2014
NL-Nieuwegein-ANTONIUS
4
05 jun. 2014
NL-Amsterdam-VUMC
4
04 feb. 2014
NL-Nijmegen-CWZ
3
10 mrt. 2014
NL-Winterswijk-SKBWINTERSWIJK
3
24 jun. 2014
NL-Eindhoven-MAXIMAMC
3
02 jun. 2014
NL-Maastricht-MUMC
3
21 jul. 2014
NL-Tilburg-ETZ
3
19 mei 2014
NL-Heerenveen-TJONGERSCHANS
3
15 apr. 2014
NL-Meppel-ISALADIACONESSEN
2
13 mrt. 2014
NL-Amsterdam-SLOTERVAART
2
20 nov. 2014
NL-Utrecht-UMCUTRECHT
2
25 jun. 2014
NL-Beverwijk-RKZ
2
28 jun. 2016
NL-Purmerend-DIJKLANDERPURMEREND
2
12 mei 2015
NL-Amsterdam-SLAZLUCAS
2
04 jun. 2014
NL-Rotterdam-ERASMUSMC
2
03 jun. 2014
NL-Den Haag-HMCWESTEINDE
2
09 okt. 2014
NL-Helmond-ELKERLIEK
1
31 mrt. 2014
NL-Enschede-MST
1
06 okt. 2014
NL-Haarlem-SPAARNEHAARLEM
1
31 jul. 2014
NL-Hoorn-DIJKLANDERHOORN
1
23 apr. 2015
NL-Sneek-ANTONIUSSNEEK
1
21 mrt. 2014
NL-Almelo-ZGTALMELO
1
30 okt. 2014
NL-Doetinchem-SLINGELAND
1
05 feb. 2014
NL-Groningen-UMCG
26 mrt. 2015
NL-Drachten-NIJSMELLINGHE
NL-Amsterdam-OLVG
NL-Delfzijl-OMMELANDERDELFZIJL
NL-Rotterdam-EMCDANIEL
03 jun. 2014
NL-Amsterdam-AMC
NL-Terneuzen-ZORGSAAM
22 okt. 2014
NL-Geldrop-STANNA
28 feb. 2014
NL-Hengelo-ZGTHENGELO
20 aug. 2014
NL-Dirksland-VANWEELBETHESDA
02 sep. 2014
NL-Almere-FLEVOZIEKENHUIS
NL-Den Haag-HMCBRONOVO
15 jul. 2014
NL-Groningen-MARTINI
28 jul. 2014
NL-Delft-RDGG
NL-Heerlen-ATRIUMMC
NL-Roermond-LZR
11 feb. 2015
NL-Rotterdam-IKAZIA
11 nov. 2014
NL-Woerden-ANTONIUSWOERDEN
= Active hospitals
= Inactive hospitals

Participating Parties

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