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

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ClinicalTrials.gov Identifier: NCT00232934
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : October 5, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : January 2002
Estimated Study Completion Date : May 2010


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response Rate
  2. Progression Free Survival
  3. Event Free Survival

Secondary Outcome Measures :
  1. Safety
  2. Overall Survival

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232934


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00232934     History of Changes
Other Study ID Numbers: GISMM2001-A
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: October 5, 2005
Last Verified: October 2005

Keywords provided by Gruppo Italiano per lo Studio del Mieloma Multiplo:
Myeloma
Thalidomide
Diagnosis
Elderly patients

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Melphalan
Thalidomide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors