HOVON HO24 MM
- HO24 MM / OG 96-020
- 1st lijn
- Included patients:
- Active sites:
0(of 39)38 sites are pending
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.
- Prospective randomized Phase II study
- Monitoring Type:
- 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.
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
The following information will be requested:
- Protocol number
- Name of caller and/or physicisan in charge.
- Institutions name.
- Patients name, date of birth and sex.
- Hospital record number.
- Stage II or III.