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

Conditions

Multiple Myeloma

Keywords

Myeloma, Thalidomide, Diagnosis, Elderly patients

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.

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, Omedè P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A.

2011-01-12199 citations

10.1182/blood-2010-09-307645

Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial.

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.

2008-05-27238 citations

10.1182/blood-2008-04-149427

Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial.

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.

2006-03-01541 citations

10.1016/s0140-6736(06)68338-4

Interventions

DRUGThalidomide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Response Rate	—
Progression Free Survival	—
Event Free Survival	—

Secondary

Measure	Time frame
Safety	—
Overall Survival	—

Countries

Italy

Outcome results

None listed