Main info

Identificatie:

HO24 MM / OG 96-020

Sponsor:

HOVON

Age:

18-65

Stadium:

1st lijn

Included patients:

453

Active sites:

0

(of 39)

38 sites are pending

Title:

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.

Timeline

Flow

Details

Phase:

Prospective randomized Phase II study

Monitoring Type:

Objectives:

Eligibility

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.

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals