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Clinical picture: MM (Multiple Myeloom)
Trial: HOVON 36 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
News
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1. Overview
Summary
A study of the efficacy, morbidity and quality of life of the standard treatment with Melphalan and Prednison versus an intensified treatment in elderly patients with Multiple Myeloma: A Phase III study.
Status
closed
Study details
Target number of patients
230
Date of activation
11-Nov-1997
Date closed
11-Nov-1999
Approved by
CKVO 97-02
Change history / amendement
HOVON 36 was closed due to high toxicity-levels, namely in the intensive arm of treatment, especially Cycle 1. It was unlikely that the aims of the study - reduced toxicity, faster response and improvement of the quality of life - would be realized. HOVON 36 had 72 registered patients.
2. Patient eligibility criteria
Inclusion criteria
Patients with multiple myeloma not yet treated with chemotherapy.
Age > 64
WHO performance status 0, 1, 2 or 3.
Salmon and Durie stages Ib, IIa, IIb, IIIa and IIIb.
A well-measurable tumor parameter.
Exclusion criteria
Severe cardiac, pulmonary or hepatic disease.
Dependency on kidney function replacement therapy.
Previously treated with cytostatics and/or alpha-interferon.
A history of second primary malignant disease other than stage I carcinoma of the cervix and non-melanomatic cancer of the skin.
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: Name of the caller
Name of the hospital
Pysician in charge of the patient�s treatment
Protocol number
Patient's initials
Hospital registration number
Date of birth
Sex
Stage (Salmon and Durie)
Previous treatment of MM with chemotherapy or IFN-alfa
Presence of a measurable tumor parameter
Informed consent
WHO performance status
Presence/absence of severe cardiac, pulmonary or liver disease
Dependency on kidney function replacement therapy
Presence of other primary malignancies
Does the patinet agree to participate in research on the quality of life?
If so, name and address of the patient
4. Participating parties
Principal investigator
PW Wijermans (hematley@worldonline.nl)
Coordinating investigator(s)
ECM van Pampus
Statistician(s)
W.L.J. van Putten (w.vanputten@erasmusmc.nl)
Central data management
A Meurisse (meurisse@stah.azr.nl)
Other functions
Statisticians:
J Hermans
Morbidity and Quality of Life Investigators:
CA Uyl-de Groot
I Buijt (E-mail Address: buijt@econ.bmg.eur.nl)
Please contact monitors at hdcmonitorteam@erasmusmc.nl
5. Participating sites
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.