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

January 10, 2011 updated by: Gruppo Italiano Studio Linfomi
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41120
        • Gruppo Italiano Studio Linfoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melphalan, prednisone plus Thalidomide
Drug: Melphalan, Prednisone and Thalidomide
Active Comparator: Melphalan and Prednisone
Drug: Melphalan, Prednisone and Thalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the efficacy
Time Frame: 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
from 8 to 12 months
To assess the toxicity
Time Frame: 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
From 1 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the Overall Survival (OS) in the 2 arms of treatment
Time Frame: 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
From 1 to 60 months
To evaluate the Duration of Remission (DR) in the 2 arms of treatment
Time Frame: 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
From 8 to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Studio Linfomi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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