Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients

Phase 3

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00232934
• Lead Sponsor: Gruppo Italiano per lo Studio del Mieloma Multiplo

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 overall survival, but multiple myeloma still remains an incurable haematological malignancy. Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%.

Due to its activity, Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2005-01
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Study Completion: 2014-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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 Criteria

• other cancer
• psychiatric disease and any grade 2 peripheral neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Response Rate
Event Free Survival
Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
Overall Survival
Safety

Trial Locations

Locations (13)

Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello; 🇮🇹 Palermo, Italy

Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza; 🇮🇹 Roma, Italy

Istituto di Ematologia - Università Cattolica; 🇮🇹 Roma, Italy

Ematologia - H.S. Gerardo; 🇮🇹 Monza, Italy

Clinica Medica I, Policlinico Monteluce; 🇮🇹 Perugia, Italy

Divisionedi Ematologia - Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Divisione di Ematologia - Az. Osp. S.Croce Carle; 🇮🇹 Cuneo, Italy

Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna; 🇮🇹 Bologna, Italy

U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza; 🇮🇹 Foggia, Italy

Cattedra e Divisione di Ematologia Università Federico II; 🇮🇹 Napoli, Italy

Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio; 🇮🇹 Roma, Italy

Divisione di Ematologia Ospedali Riuniti; 🇮🇹 Reggio Calabria, Italy

Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista; 🇮🇹 Torino, Italy