Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients - Full Text View

Sponsor:	Gruppo Italiano per lo Studio del Mieloma Multiplo
Information provided by:	Gruppo Italiano per lo Studio del Mieloma Multiplo
ClinicalTrials.gov Identifier:	NCT00232934

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: Thalidomide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Thalidomide Prednisone Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by Gruppo Italiano per lo Studio del Mieloma Multiplo:

Primary Outcome Measures:

Response Rate
Progression Free Survival
Event Free Survival

Secondary Outcome Measures:

Safety
Overall Survival

Estimated Enrollment:	400
Study Start Date:	January 2002
Estimated Study Completion Date:	May 2010

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Istituto di Ematologia - Università Cattolica
Roma, Italy, 00168
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
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:

San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58. Review.

Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. Erratum in: N Engl J Med 2000 Feb 3;342(5):364.

Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, Treon SP, Lin B, Schlossman RL, Richardson P, Muller G, Stirling DI, Anderson KC. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood. 2000 Nov 1;96(9):2943-50.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omedè P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A. Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients. Blood. 2011 Mar 17;117(11):3025-31. Epub 2011 Jan 12.

Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. Epub 2008 May 27.

Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31.

ClinicalTrials.gov Identifier:	NCT00232934 History of Changes
Other Study ID Numbers:	GISMM2001-A
Study First Received:	October 4, 2005
Last Updated:	October 4, 2005
Health Authority:	Italy: Ministry of Health

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
Melphalan

Prednisone
Thalidomide
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012