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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274403
• Other study ID #: MM03
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2010
• Last updated: January 10, 2011

Study information

• Verified date: December 2010
• Source: Gruppo Italiano Studio Linfomi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Melphalan, Prednisone and Thalidomide

Locations

Country	Name	City	State
Italy	Gruppo Italiano Studio Linfoma	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy	To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment	from 8 to 12 months	No
Primary	To assess the toxicity	To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0	From 1 to 12 months	Yes
Secondary	To evaluate the Overall Survival (OS) in the 2 arms of treatment	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	From 1 to 60 months	No
Secondary	To evaluate the Duration of Remission (DR) in the 2 arms of treatment	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	From 8 to 60 months	No