Multiple Myeloma Clinical Trial
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.
Verified date | August 2018 |
Source | Gruppo Italiano per lo Studio del Mieloma Multiplo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | November 2014 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Divisionedi Ematologia - Ospedali Riuniti | Bergamo | |
Italy | Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna | Bologna | |
Italy | Divisione di Ematologia - Az. Osp. S.Croce Carle | Cuneo | |
Italy | U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza | Foggia | |
Italy | Ematologia - H.S. Gerardo | Monza | |
Italy | Cattedra e Divisione di Ematologia Università Federico II | Napoli | |
Italy | Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello | Palermo | |
Italy | Clinica Medica I, Policlinico Monteluce | Perugia | |
Italy | Divisione di Ematologia Ospedali Riuniti | Reggio Calabria | |
Italy | Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio | Roma | |
Italy | Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza | Roma | |
Italy | Istituto di Ematologia - Università Cattolica | Roma | |
Italy | Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista | Torino |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano per lo Studio del Mieloma Multiplo |
Italy,
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. — View Citation
San Miguel JF, Bladé Creixenti J, García-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | |||
Primary | Progression Free Survival | |||
Primary | Event Free Survival | |||
Secondary | Safety | |||
Secondary | Overall Survival |
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