Status:
UNKNOWN
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients
Lead Sponsor:
Nordic Myeloma Study Group
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a randomised, placebo controlled, phase II study evaluating toxicity and safety of fludarabine added to CyDex (cyclophosphamide+dexamethasone) as induction therapy in younger patients with unt...
Eligibility Criteria
Inclusion
- Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00382694
Start Date
May 1 2005
End Date
December 1 2006
Last Update
September 29 2006
Active Locations (6)
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1
Department of Haematology B, Aalborg Hospital, University of Aarhus
Aalborg, Denmark, 9000
2
Dept. of Haematology, Århus University Hospital
Aarhus, Denmark, 8000
3
Department of Haematology, Herlev University Hospital
Herlev, Denmark, 2730
4
Department of Haematology, Rigshospitalet
København Ø, Denmark, 2100