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Search / Trial NCT00232934

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

Launched by GRUPPO ITALIANO PER LO STUDIO DEL MIELOMA MULTIPLO · Oct 4, 2005

Trial Information

Current as of June 30, 2025

Completed

Keywords

Myeloma Thalidomide Diagnosis Elderly Patients

ClinConnect Summary

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 fo...

Gender

ALL

Eligibility criteria

  • 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

About Gruppo Italiano Per Lo Studio Del Mieloma Multiplo

The Gruppo Italiano per lo Studio del Mieloma Multiplo (GISMM) is a leading Italian research organization dedicated to advancing the understanding and treatment of multiple myeloma. Composed of a network of hematologists and oncology specialists, GISMM focuses on conducting high-quality clinical trials, fostering collaborative research, and promoting innovative therapies to improve patient outcomes. By prioritizing patient-centered approaches and integrating multidisciplinary expertise, GISMM aims to enhance the overall care and quality of life for individuals affected by this complex hematological malignancy.

Locations

Bergamo, , Italy

Bologna, , Italy

Cuneo, , Italy

Foggia, , Italy

Monza, , Italy

Napoli, , Italy

Palermo, , Italy

Perugia, , Italy

Reggio Calabria, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Torino, , Italy

Patients applied

0 patients applied

Trial Officials

Mario Boccadoro, MD

Principal Investigator

Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

Antonio Palumbo, MD

Study Director

Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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