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

August 1, 2018 updated by: Gruppo Italiano per lo Studio del Mieloma Multiplo

Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 3

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
      • Bergamo, Italy, 24127
        • Divisionedi Ematologia - Ospedali Riuniti
      • Bologna, Italy, 40138
        • Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
      • Cuneo, Italy, 26100
        • Divisione di Ematologia - Az. Osp. S.Croce Carle
      • Foggia, Italy, 71013
        • U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
      • Monza, Italy, 20052
        • Ematologia - H.S. Gerardo
      • Napoli, Italy, 80131
        • Cattedra e Divisione di Ematologia Università Federico II
      • Palermo, Italy, 90146
        • Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello
      • Perugia, Italy, 06123
        • Clinica Medica I, Policlinico Monteluce
      • Reggio Calabria, Italy, 89100
        • Divisione di Ematologia Ospedali Riuniti
      • Roma, Italy, 00100
        • Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio
      • Roma, Italy, 00161
        • Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza
      • Roma, Italy, 00168
        • Istituto di Ematologia - Università Cattolica
      • Torino, Italy, 10126
        • Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response Rate
Event Free Survival
Progression Free Survival

Secondary Outcome Measures

Outcome Measure
Safety
Overall Survival

Collaborators and Investigators

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

Sponsor

Gruppo Italiano per lo Studio del Mieloma Multiplo

Investigators

  • Principal Investigator: Mario Boccadoro, MD, Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
  • Study Director: Antonio Palumbo, MD, Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GISMM2001-A

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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