Status:
COMPLETED
Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients
Lead Sponsor:
Gruppo Italiano per lo Studio del Mieloma Multiplo
Conditions:
Multiple Myeloma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.
Detailed Description
Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years. Advances in systemic and supportive therapy increased remission rates and o...
Eligibility Criteria
Inclusion
- untreated myeloma patients
- age \>65 years of age or younger but excluded from transplant procedure
- Durie \& Salmon stage II or III myeloma and measurable disease.
- Patients agreed to use contraception
Exclusion
- other cancer
- psychiatric disease and any grade 2 peripheral neuropathy
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00232934
Start Date
January 1 2002
End Date
November 1 2014
Last Update
August 2 2018
Active Locations (13)
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1
Divisionedi Ematologia - Ospedali Riuniti
Bergamo, Italy, 24127
2
Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
Bologna, Italy, 40138
3
Divisione di Ematologia - Az. Osp. S.Croce Carle
Cuneo, Italy, 26100
4
U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
Foggia, Italy, 71013