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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 123 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


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News


HOVON 123 MM

25 August 2017:

Protocol version 7 (9 august 2017) is active

 

2015: link to eCRF: https://prod.tenalea.net/emc/DM/DELogin.aspx?refererPATH=DEHome.aspx

 

Updated documents:

21-02-2017: New version of SAE report form (new fax number) 

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

 


1. Overview



Summary

Toxicity of the treatment leading to discontinuation of therapy with an inferior outcome as a consequence remains a concern in elderly patients with MM. This study aims to assess the feasibility of a dose-adjusted MPV scheme in patients ≥75 years of age and to assess the value of geriatric assessments to predict both feasibility and efficacy.


Status

closed



Type of study

Prospective Phase II study


Echelon level

Level D


Type of monitoring for this study

Site evaluation visits


Target number of patients

240


Current number of patients

240


Date of activation

07-Jan-2014


Date closed

17-May-2017


Approved by

EudraCT nr.:2013-000320-33
CKTO: VU2013-6411
METC-VUMC: 2013.287
Approval date METC: 14-NOV-2013


Change history / amendement

AM 1 (sites) approved by Central METC (VUMC)
AM 2 (sites) approved by Central METC (VUMC)
AM 3 (sites) approved by Central METC (VUMC)
AM 4 (ICF) approved by Central METC (VUMC)
AM 5 (sites) approved by Central METC (VUMC)
AM 6 (protocol & ICF) approved by Central METC
AM 7 (protocol & ICF) approved by Central METC
AM 8 (protocol) approved by Central METC


Study objectives

• To assess the feasibility, defined as discontinuation rate, of a dose-adjusted MPV scheme in the MM patients ≥ 75 years of age
• To assess toxicity
• To assess efficacy determined 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 with respect to feasibility and efficacy
• To assess QoL
• To explore the value of biomarkers reflecting biological age in predicting the toxicity and feasibility of the treatment regimen
• To analyze the value of polymorphisms 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
• To explore the incidence of bone remodeling during treatment and the relation with response to therapy
• Cost effectiveness analysis


2. Patient eligibility criteria



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


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



1- protocol number
2- Institution name
3-Name caller/responsible investigator
4-sex
5-date of birth
6-date written informed consent
7-specific items patient gives consent for (see ICF)
8-Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof. Dr. S. Zweegman (VUMC)


Co-Investigator(s)

N.W.C.J. van de Donk (VUMC)
Dhr. M.D. Levin (A. Schweitzer ZH, Dordwijk)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)


Statistician(s)

Dhr. K. Nasserinejad (Erasmus MC - Centrum)


Central Data Manager(s)

K. Nowek (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. T. van de Klundert (Erasmus MC - Daniel)
M. Spaans (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Dhr. Dr. M. van Duin (Erasmus MC - Daniel)
Central Coordinator - Special Investigations - Myeloma Research Lab-EMC (Erasmus MC - Centrum)
Central Coordinator - Special Investigations - Mw. E. Wagter (VUMC)
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)


Trial manager

H.A. Visser-Wisselaar (h.visser-wisselaar@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Alkmaar-MC Alkmaar
8
NL-Almelo-Ziekenhuisgroep Twente, loc. Almelo
1
NL-Amersfoort-Meander MC
11
NL-Amstelveen-Ziekenhuis Amstelland
11
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
2
NL-Amsterdam-Slotervaart Ziekenhuis
2
NL-Amsterdam-VUMC
4
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
4
NL-Arnhem-Ziekenhuis Rijnstate
6
NL-Beverwijk-Rode Kruis Ziekenhuis
2
Show 48 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



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