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

Gruppo Italiano per lo Studio del Mieloma Multiplo

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00232934

GISMM2001-A

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)