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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 24 MM / OG 96-020


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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1. Overview



Summary

Myelo-Ablative Chemo-/ Radiotherapy and Autologous Stem Cell Transplantation as compared to only Chemotherapy in Patients with Multiple Myeloma: A Prospective Randomized Phase III Study.


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Date of activation

15-Nov-1995


Date closed

01-Apr-2000


Approved by

Dutch Cancer Foundation: CKVO
National Health Council of the Netherlands: OG 96-020


2. Patient eligibility criteria



Inclusion criteria

Patients under 66 years of age with previously untreated Multiple Myeloma and patients who have received a maximum of two courses of melphalan, prednisone or VMCP may be included in the study.
The patient must give informed consent according to the rules of the hospital.

Inclusion Criteria for IFN maintenance and PBSCT or ABMT:
At least PR after induction.
WHO performance status 0-2.
Suitable peripheral stem of bone marrow graft.
No active infections.
Absence of severe cardiac, pulmonary, neurologic or psychiatric disease.
Serum creatinine, bilirubine and transaminases of less than 2.5 times the upper limit of normal values.
Platelet count > 50 x 109/l.
Absolute neutrophil count > 1 x 109/l.
Informed consent.


Exclusion criteria

Age above 65 years.
WHO performance status 4.
Severe cardiac, pulmonary, neurologic or metabolis disease.
Inadequate liver function.
Patients with prior malignancies, except non-melanoma skin tumors or stage 0 cervical carcinoma.
Patients with prior extensive radiotherapy involving the myelum.


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
Name of caller and/or physicisan in charge.
Institution�s name.
Patient�s name, date of birth and sex.
Hospital record number.
Stage II or III.


4. Participating parties



Principal investigator

HM Lokhorst (H.Lokhorst@digd.azu.nl)


Coordinating investigator(s)

CM Segeren (segeren@haed.azr.nl)
P Sonneveld (sonneveld@haed.azr.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)
B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

MMC Steijaert (steijaert@stah.azr.nl)


Central data management

PHM Westveer (westveer@stah.azr.nl)


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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