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Completed

NCT Number: NCT00232934

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Divisionedi Ematologia - Ospedali Riuniti, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thalidomide

Drug

Primary outcomes

  1. Response Rate

  2. Progression Free Survival

  3. Event Free Survival

Secondary outcomes

  1. Safety

  2. Overall Survival

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per lo Studio del Mieloma Multiplo

Other

Registry information

Official study title

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.

Important dates

Study start
2002
Primary completion
2005
Study completion
2014
First posted
Oct 5, 2005
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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