Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

• Status: Unknown status
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Multiple myeloma is an incurable malignant disease which evnetuelly will relapse after primary treatment. Clonal B-cells have been identified and in theory these cells might be sleeping during primary treatment and be responsible for later relapse. Fluarabine has documented effect on both resting and dividing cells including B-cells. The protocol aim at evaluating safety and toxicity of adding fludarabine to induction chemotherapy with cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell support.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Myeloma Study Group
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation.

Exclusion Criteria:

• Severe uncontrolled clinical or microbiological evidence of infection at the time of enrolment.

• Other active malignancy.

• Severe coincident heart or lung disease including uncontrolled hypertension, unstable angina, congestive heart failure, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled cardiac arrhythmia.

• Other severe illness including poorly controlled diabetes.

• Haemolytic anaemia (Coombs positive without evidence of haemolysis is accepted).

• Idiopathic thrombocytopenic purpura.

• Terminal illness.

• Allogenic transplantation planned within 6 months.

• Chemotherapy before inclusion.

• Pregnancy or breast-feeding, or inadequate contraceptive precautions.

• Psychiatric disease, abuse of alcohol or narcotics, or any other disorder that might compromise the patients ability to give informed consent.