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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 49 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


HO49 news

On 31 December 2014 HOVON 49 MM was closed. No further data will be collected.

1. Overview



Summary

Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.


Status

closed



Type of study

Prospective randomized Phase III study


Target number of patients

420


Current number of patients

344


Date of activation

01-Aug-2002


Date closed

15-Jul-2007


Approved by

CKTO: CKTO 2002-04, 25 June 2002
MEC: METC Ziekenhuis Leyenburg, 15 July 2002


Study objectives

To study the efficacy of the addition of low dose Thalidomide to the Melphalan + Prednisone therapy in previously untreated myeloma patients, as measured by the event free survival. Events are induction failure, disease progression and death from any cause.
To evaluate the response rate, overall survival and progression free survival.
To assess the safety and toxicity of the addition of Thalidomide to the combination therapy with Melphalan and Prednisone.
To assess the effect of the addition of Thalidomide on quality of life.


2. Patient eligibility criteria



Inclusion criteria

Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria (Appendix A)
Age > 65 years
WHO performance status 0-3 (see appendix D)
Measurable tumorparameter (M-protein or Bence Jones prote﮵ria)
Written informed consent.


Exclusion criteria

Known intolerance to Thalidomide
Systemic AL amyloidosis
Polyneuropathy
Severe cardiac dysfunction (NYHA classification II-IV, appendix E)
Severe pulmonary dysfunction
Significant hepatic dysfunction (total bilirubin >= 30 umol/l or transaminases >= 2.5 times normal level), unless related to myeloma
Renal failure with dependency on dialysis
Patients with active, uncontrolled infections
Pre-treatment with cytostatic drug or alpha interferon
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


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
Patient?s initials or code
Patient?s hospital record number
Sex
Date of birth
Date of diagnosis of multiple myeloma
Planned date of start cycle 1
Will the patient participate in the quality of life assessment?
Eligibility criteria.


4. Participating parties



Principal Investigator(s)

Dr. A. Koster (VieCuri loc. Venlo)
Dhr. Dr. M.R. Schaafsma (Medisch Spectrum Twente)
Dhr. Dr. P.W. Wijermans (Hagaziekenhuis, locatie Leyweg)


Statistician(s)

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


Other functions

Central Coordinator - QoL - Dr. A. Koster (VieCuri loc. Venlo)
Reviewer - Cytogenetics - Dhr. Dr. A. Buijs (UMCU)
Reviewer - Cytogenetics - Mw. A. Simons (Radboudumc)
Reviewer - Cytogenetics - Mw. Dr. M.J.P.L. Stevens-Kroef (Radboudumc)


Principal investigator

P.W. Wijermans


Coordinating investigator(s)

M.R. Schaafsma


Statistician(s)

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


Trial manager

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


Central data management


5. Participating sites



Site
Included patients *
NL-Amersfoort-Meander MC
19
NL-Amstelveen-Ziekenhuis Amstelland
3
NL-Amsterdam-AMC
7
NL-Amsterdam-OLVG
4
NL-Amsterdam-Slotervaart Ziekenhuis
1
NL-Amsterdam-VUMC
13
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
5
NL-Arnhem-Ziekenhuis Rijnstate
2
NL-Assen-Wilhelmina Ziekenhuis
1
NL-Breda-Amphia ziekenhuis, locatie Langendijk
13
Show 55 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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