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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 123 MM


News
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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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



Study details



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. Dr. 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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