Status:
COMPLETED
Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
Lead Sponsor:
Università Politecnica delle Marche
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with mul...
Detailed Description
Thalidomide has already been used as maintenance and/or consolidation after high-dose therapy followed by autologous stem cell transplantation. Despite a number of phase II and III studies the issues ...
Eligibility Criteria
Inclusion
- patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
- Written consent
Exclusion
- peripheral neuropathy \>= grade 2
- neutropenia \< 1000/mcl or thrombocytopenia \< 50000/mcl
- severe depression
- organ disfunction \> grade 2
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00633542
Start Date
June 1 2003
End Date
October 1 2007
Last Update
March 12 2008
Active Locations (1)
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1
Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Ancona, Italy, 60020