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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 87 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


HO87 news

19 October 2012
The HOVON 87 MM/NMSG 18 study is closed for entry of new patients, because it has reached its target of 668 patients.

  

New downloads:

14 November 2018: New version of SAE form and SPM form are available

31 October 2018: New version of WMO is available

29 March 2018: CRF version (March 29, 2018) is available with new address in header.

06 June 2013: 'Statement of expenses form' (new roomnumber) available under heading 'news'.

20 September 2012: New version of flowsheet is available.

09 May 2012: New version of protocol is available.

12 October 2011: New lab manual - NL is available.

 

 

 

 


1. Overview



Summary

Prospective phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Echelon level

Level D


Echelon level specification

Level D


Type of monitoring for this study

Site evaluation visits


Target number of patients

668


Current number of patients

643


Date of activation

26-Jan-2009


Date closed

19-Oct-2012


Approved by

EudraCTnr.: 2007-004007-34
CKTO: 2008 - 4246, 09-JUL-2008
MEC: METC VUMC, - 2008/256, 20-NOV-2008


Change history / amendement

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


Study objectives

To compare progression free survival with MP-Thal followed by thalidomide maintenance versus MP-Len followed by maintenance with lenalidomide
To compare (stringent) complete and very good partial response with MP-Thal versus
MP-Len
To compare overall survival with MP-Thal versus MP-Len
To assess and compare overall response* with MP-Thal versus MP-Len
To assess time to maximum response with MP-Thal versus MP-Len
To assess the effect of maintenance therapy with thalidomide alone following MP-Thal induction or lenalidomide following MP-Len, in terms of improvement of response
To assess and compare the time from relapse/progression (after initial response) to death in patients having been treated with MP-Thal versus MP-Len
To asses the impact on the quality of life of thalidomide compared with lenalidomide
To assess the safety and toxicity of induction of both regimens
* overall response will be defined as (stringent) complete response, very good partial response and partial response (appendix C)


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 > 65 years or patients <= 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation
WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients >=75 years (see appendix E)
Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy (see appendix A for definitions)
Written informed consent


Exclusion criteria

Non-secretory MM
Known hypersensitivity to thalidomide
Systemic AL amyloidosis
Polyneuropathy, grade 2 or higher
Severe cardiac dysfunction (NYHA classification II-IV, appendix F)
Severe pulmonary dysfunction
Significant hepatic dysfunction (total bilirubin >= 30 mcmol/l or transaminases >= 3 times normal level), unless related to myeloma
Creatinine clearance <30 ml/min
Patients with active, uncontrolled infections
Pre-treatment with cytostatic drug, 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 HIV-positive
History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
Not able and/or not willing to use adequate contraception
Pregnancy


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:



Protocol number
Institution name
Name of caller/responsible investigator
Sex
Date of birth
Date written informed consent
ISS stage
Will patient participate in the quality of life study
'Risk Management Program' is discussed with patient
Approval for bone marrow storage for scientific research
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof. Dr. S. Zweegman (VUMC)


Co-Investigator(s)

Dhr. Dr. G.M.J. Bos (AZ Maastricht)
Dr. U.H Mellqvist (Sahlgrenska sjukhuset)
Dr. M. Salomo (Rigshospitalet Copenhagen)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)


Coordinating Investigator(s)

Dhr. A. Waage (St. Olav univ Hospital)


Statistician(s)

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


Central Data Manager(s)

R. Fakkert (Erasmus MC - Daniel)
Mw. A.C. Gussinklo (Erasmus MC - Daniel)
Mw. M. Vania (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 Pharmacist - Dhr. Dr. P. M. Bet (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)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

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


Central data management

A.C. Gussinklo (a.gussinklo@erasmusmc.nl)
K. Nowek (k.nowek@erasmusmc.nl)


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
3
DK-Copenhagen-Rigshospitalet Copenhagen
14
DK-Herlev-Herlev Hospital
2
DK-Odense-Odense Universitetshospital
3
DK-Vejle-Vejle Hospital
9
NL-Alkmaar-MC Alkmaar
14
NL-Almelo-Ziekenhuisgroep Twente, loc. Almelo
2
NL-Amersfoort-Meander MC
16
NL-Amstelveen-Ziekenhuis Amstelland
5
NL-Amsterdam-AMC
3
Show 88 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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