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

Condition(s) targeted: Multiple Myeloma

Intervention: Thalidomide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gruppo Italiano per lo Studio del Mieloma Multiplo

Official(s) and/or principal investigator(s):
Mario Boccadoro, MD, Principal Investigator, Affiliation: Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
Antonio Palumbo, MD, Study Director, Affiliation: Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

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.

Official title: Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Response Rate

Progression Free Survival

Event Free Survival

Secondary outcome:

Safety

Overall Survival

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino 10126, Italy

Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio, Roma 00100, Italy

U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza, Foggia 71013, Italy

Clinica Medica I, Policlinico Monteluce, Perugia 06123, Italy

Divisione di Ematologia Ospedali Riuniti, Reggio Calabria 89100, Italy

Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello, Palermo 90146, Italy

Divisione di Ematologia - Az. Osp. S.Croce Carle, Cuneo 26100, Italy

Ematologia - H.S. Gerardo, Monza 20052, Italy

Divisionedi Ematologia - Ospedali Riuniti, Bergamo 24127, Italy

Cattedra e Divisione di Ematologia Università Federico II, Napoli 80131, Italy

Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna, Bologna 40138, Italy

Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza, Roma 00161, Italy

Istituto di Ematologia - Università Cattolica, Roma 00168, Italy

Related publications:

San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58. Review.

Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. Erratum in: N Engl J Med 2000 Feb 3;342(5):364.

Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, Treon SP, Lin B, Schlossman RL, Richardson P, Muller G, Stirling DI, Anderson KC. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood. 2000 Nov 1;96(9):2943-50.

Starting date: January 2002
Ending date: May 2010
Last updated: October 4, 2005