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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Melphalan, Prednisone and Thalidomide

• Registration Number: NCT01274403
• Lead Sponsor: Gruppo Italiano Studio Linfomi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2011-01-10
• Last Update Submitted: 2011-01-10
• Study First Posted: 2011-01-11
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Melphalan, prednisone plus Thalidomide	Melphalan, Prednisone and Thalidomide	-
Melphalan and Prednisone	Melphalan, Prednisone and Thalidomide	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy	from 8 to 12 months	To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
To assess the toxicity	From 1 to 12 months	To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0

Secondary Outcome Measures

Name	Time	Method
To evaluate the Overall Survival (OS) in the 2 arms of treatment	From 1 to 60 months	OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause
To evaluate the Duration of Remission (DR) in the 2 arms of treatment	From 8 to 60 months	DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination

Trial Locations

Locations (1)

Gruppo Italiano Studio Linfoma; 🇮🇹 Modena, Italy