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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 129 PCL


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


No news


1. Overview



Summary

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)


Status

open


Members

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



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

116


Current number of patients

0


Date of activation

10-Aug-2015


Approved by

central EC NL VUmc
CCMO

central EC BE Clinique Universitaires Saint-Luc
FAGG


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 adequate contraception during the study. Sperm could be frozen from men with child wish before start of treatment
Negative pregnancy test at entry (if applicable)
Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program (PPP)


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



Registration

EMN Research Italy
Via Saluzzo 1/A
10125 Torino, Italy
tel. +39 3924398409
fax. +390110133182
e-mail: amministrazione@emnresearch.it


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)

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


Co-Investigator(s)

Dr. P. Musto (IRCCS-CROB)


Coordinating Investigator(s)

Prof. N. Abildgaard (Odense Universitetshospital)
Prof. Dr. M. Delforge (UZ Gasthuisberg)
Prof.Dr. H. Einsele (Universitätsklinikum Würzburg)
Dr. S. Lenhoff (Skanes University Hospital Lund)
Mr.Dr. F.H. Schjesvold (Oslo Universitetssykehus)
Ms.dr. A.J. Vangsted (Rigshospitalet Copenhagen)


Statistician(s)

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


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. T. van de Klundert (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 (n.vandedonk@vumc.nl)
P. Musto (pellegrino.musto@crob.it)


Coordinating investigator(s)

N.W.C.J. van de Donk (n.vandedonk@vumc.nl)
P. Musto (pellegrino.musto@crob.it)
H. Einsele (einsele_h@medizin.uni-wuerzburg.de)
A. Vangsted (avag@regionsjaelland.dk)
N. Abilgaard (niels.abildgaard@ouh.fyns-amt.dk)
A. Waage (anders.waage@ntnu.no)
O. Stromberg (olga.stromberg@karolinska.se)
M. Delforge (michel.delforge@uzleuven.be)
R. benjamin (reuben.benjamin@kcl.ac.uk)


Trial manager

T. Gussinklo (a.gussinklo@erasmusmc.nl)


Central data management

EMN Research Italy


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
0
BE-Antwerpen Edegem-Universitair Ziekenhuis Antwerpen
0
DK-Copenhagen-Rigshospitalet Copenhagen
0
NL-Amsterdam-VUMC
0
NL-Groningen-UMCG
0
NL-Rotterdam-Erasmus MC - Centrum
0
NL-Utrecht-UMCU
0

* 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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