Clinical trial NCT00232934: Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Myeloma
Thalidomide
Diagnosis
Elderly patients
Lead sponsor: Gruppo Italiano per lo Studio del Mieloma Multiplo
Sponsor class: OTHER
First posted: 2005-10-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response Rate
measure: Progression Free Survival
measure: Event Free Survival
Secondary outcomes:
measure: Safety
measure: Overall Survival
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Divisionedi Ematologia - Ospedali Riuniti
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
city: Cuneo
country: Italy
facility: Divisione di Ematologia - Az. Osp. S.Croce Carle
city: Foggia
country: Italy
facility: U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
city: Monza
country: Italy
facility: Ematologia - H.S. Gerardo
city: Napoli
country: Italy
facility: Cattedra e Divisione di Ematologia Università Federico II
city: Palermo
country: Italy
facility: Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello
city: Perugia
country: Italy
facility: Clinica Medica I, Policlinico Monteluce
city: Reggio Calabria
country: Italy
facility: Divisione di Ematologia Ospedali Riuniti
city: Roma
country: Italy
facility: Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio
city: Roma
country: Italy
facility: Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza
city: Roma
country: Italy
facility: Istituto di Ematologia - Università Cattolica
city: Torino
country: Italy
facility: Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista
Study officials:
affiliation: Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
name: Mario Boccadoro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
name: Antonio Palumbo, MD
role: STUDY_DIRECTOR
References:
citation: San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58.
citation: 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. doi: 10.1056/NEJM199911183412102.
citation: 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.
citation: Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omede P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A. Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients. Blood. 2011 Mar 17;117(11):3025-31. doi: 10.1182/blood-2010-09-307645. Epub 2011 Jan 12.
citation: Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.
citation: Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.