A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma

Gruppo Italiano Studio Linfomi

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Melphalan, Prednisone and Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01274403

MM03

Details and patient eligibility

About

The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.

Enrollment: 130 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed of multiple myeloma.
• Age > 65 years
• ECOG <= 3
• Written informed consent given at the time of randomization
• Patients with age <= 65 but not eligible for high dose treatment with stem cells support

Exclusion criteria

• ECOG > 3
• current neoplasm..
• contraindications to use thalidomide
• peripheral neurophaty

Trial design

130 participants in 2 patient groups

Melphalan, prednisone plus Thalidomide

Experimental group

Treatment:

Drug: Melphalan, Prednisone and Thalidomide

Melphalan and Prednisone

Active Comparator group

Treatment:

Drug: Melphalan, Prednisone and Thalidomide