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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 129 PCL

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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HO129 news

20Apr2020: De nieuwe versie (v3) van pharmacy info letter is hieronder te vinden onder 'other documents'.

1. Overview


Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients

A European Intergroup Trial of the European Myeloma Network EMN (EMN12/HO129 PCL)




Participating groups: NSMG, DSMM, GIMEMA, HOVON, UK

Uitleg patienten informatie

Beste patient, hieronder vindt u een link naar de patienten informatie die beschikbaar is voor deze studie. Mochten er vragen zijn, dan kunt u deze het beste stellen aan uw behandelend arts.

 Patienten informatie

Study details

Type of study

Prospective randomized Phase II study

Echelon level

Level A

Echelon level specification

Allo transplantation centers.

Type of monitoring for this study

Site evaluation visits

Target number of patients


Current number of patients


Date of activation


Approved by

central EC NL VUmc

central EC BE Clinique Universitaires Saint-Luc

Study objectives

To evaluate progression-free survival in adult pPCL patients by incorporation of carfilzomib and lenalidomide in induction, consolidation, and maintenance therapy
To assess overall response rate and (s)CR + VGPR ((stringent) complete and very good partial response) rate after induction therapy, after HDM, after CRd consolidation, after RIC allo-SCT or a second HDM, and during maintenance.
To evaluate overall survival.
To assess safety and toxicity
To assess the prognostic value of risk factors at diagnosis, including β2-microglobulin, LDH, FISH abnormalities del1p, ampli 1q, t(4;14), t(14;16), t(11;14), ampli 9, del13q/13-, del17p as analyzed in purified bone marrow plasma cells with respect to progression-free survival
To analyze the prognostic value of myeloma gene expression profiles
To analyze the prognostic value of minimal-residual disease negativity
To assess the prognostic value of mutations as determined by sequencing
To establish the frequency of second primary malignancies (SPM)

2. Patient eligibility criteria

Inclusion criteria

Patients with diagnosis of symptomatic pPCL (see appendix A)
Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 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)
Age ≥18 years
WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL and not by co-morbid conditions)
Written informed consent
Patient capable of giving informed consent (patient is legally, physically and mentally capable of giving consent)
All men and women of childbearing potential should use highly effective contraception during the study. Men should be offered sperm banking before starting treatment (if applicable).
Negative pregnancy test at entry (if applicable)
Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program (PPP) throughout study treatment

Exclusion criteria

Any current CNS involvement with disease refractory to intrathecal chemotherapy.
Female patients who are pregnant or breast feeding.
HIV positive patients
Active malignancy other than pPCL requiring treatment, or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
Patients with active, uncontrolled infections
Severe neurological or psychiatric disease
Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) - Myocardial infarction within 6 months, unstable angina, and cardiac arrhythmias which are not controlled by conventional treatment (including medications and cardiac devices)
Severe pulmonary dysfunction
Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3.0 times normal level), unless related to pPCL
Patients with GFR < 15 ml/min
Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize carfilzomib)
Hypersensitivity to the active substances or to any of the excipients of the drug products
Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days for symptom control or stabilization(this includes dexamethasone 40 mg daily) or inthrathecal chemotherapy in case of CNS involvement
Systemic AL amyloidosis
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

3. Registration (& randomization) of patients


EMN Research Italy
Via Saluzzo 1/A
10125 Torino, Italy
tel. +39 3924398409
fax. +390110133182

Patients are registered through the website of EMN Research Italy:

Registration criteria

The following information will be requested:

Protocol number
Institution name
Name of responsible investigator
Age on inclusion
Date of informed consent
Date of sample shipment (optional)
Date of diagnosis of pPCL
Criteria for measurable disease
Serum β2-microglobulin
Serum albumin
Eligibility criteria

4. Participating parties

Principal Investigator(s)

Dr. N.W.C.J. van de Donk (VUMC)
Dr. P. Musto (IRCCS-CROB)


Dr. P. Musto (IRCCS-CROB)

Coordinating Investigator(s)

Prof. Dr. R. Hajek (University Hospital Ostrava)
Mr.Dr. F.H. Schjesvold (Oslo Universitetssykehus)
Ms.dr. A.J. Vangsted (Rigshospitalet Copenhagen)
Dhr. Dr. K.L. Wu (ZNA Stuivenberg)


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

Monitor - Site Evaluation Visits

Mw. I. Enthoven (Erasmus MC - Daniel)
Mw. W.M. Keller (Erasmus MC - Daniel)
Mw. J. Kromme (Erasmus MC - Daniel)

Other functions

Central Coordinator - Molecular Diagnostics - Dhr. Dr. M. van Duin (Erasmus MC - Daniel)

Principal investigator

N.W.C.J. van de Donk (
P. Musto (

Coordinating investigator(s)

P. Musto (
M.C. Vekemans (
A. Vangsted (
F. Schjevold ( )
R. Hajek (
M. Dimopoulos (
R. Benjamin (

Trial manager

W. Razawy (

Central data management

EMN Research Italy

De EMN database is een Access database en is te downloaden via de EMN website

5. Participating sites

Included patients *
BE-Antwerpen-ZNA Stuivenberg
BE-Antwerpen Edegem-Universitair Ziekenhuis Antwerpen
BE-Brugge-Algemeen Ziekenhuis St. Jan
BE-Liege-CHU Liege
CZ-Brno-University Hospital BRNO
CZ-Hradec Kralove-University Hospital Hradec Kralove
CZ-Ostrava-Poruba-University Hospital Ostrava
DK-Aarhus N-Aarhus University Hospital
DK-Copenhagen-Rigshospitalet Copenhagen
DK-Odense-Odense Universitetshospital
Show 13 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

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