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

NCT ID: NCT00232934

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thalidomide

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano per lo Studio del Mieloma Multiplo

OTHER

Sponsor Role: lead

Principal Investigators

Mario Boccadoro, MD

Role: PRINCIPAL_INVESTIGATOR

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

Antonio Palumbo, MD

Role: STUDY_DIRECTOR

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

Locations

Divisionedi Ematologia - Ospedali Riuniti

Bergamo, , Italy

Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna

Bologna, , Italy

Divisione di Ematologia - Az. Osp. S.Croce Carle

Cuneo, , Italy

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

Foggia, , Italy

Ematologia - H.S. Gerardo

Monza, , Italy

Cattedra e Divisione di Ematologia Università Federico II

Napoli, , Italy

Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello

Palermo, , Italy

Clinica Medica I, Policlinico Monteluce

Perugia, , Italy

Divisione di Ematologia Ospedali Riuniti

Reggio Calabria, , Italy

Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio

Roma, , Italy

Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza

Roma, , Italy

Istituto di Ematologia - Università Cattolica

Roma, , Italy

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

Torino, , Italy

Countries

Italy

References

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

Reference Type: BACKGROUND

PMID: 10091392 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10564685 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11049970 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21228328 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18505783 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 16530576 (View on PubMed)

Other Identifiers

GISMM2001-A

Identifier Type: -

Identifier Source: org_study_id