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

Sponsor

Gruppo Italiano per lo Studio del Mieloma Multiplo (Other)

Overall Status

Completed

CT.gov ID

NCT00232934

Collaborator

(none)

400

Enrollment

Locations

154

Actual Duration (Months)

30.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

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.

Actual Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Nov 1, 2014

Outcome Measures

Primary Outcome Measures

Response Rate []
Progression Free Survival []
Event Free Survival []

Secondary Outcome Measures

Safety []
Overall Survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Divisionedi Ematologia - Ospedali Riuniti	Bergamo	Italy	24127
2	Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna	Bologna	Italy	40138
3	Divisione di Ematologia - Az. Osp. S.Croce Carle	Cuneo	Italy	26100
4	U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza	Foggia	Italy	71013
5	Ematologia - H.S. Gerardo	Monza	Italy	20052
6	Cattedra e Divisione di Ematologia Università Federico II	Napoli	Italy	80131
7	Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello	Palermo	Italy	90146
8	Clinica Medica I, Policlinico Monteluce	Perugia	Italy	06123
9	Divisione di Ematologia Ospedali Riuniti	Reggio Calabria	Italy	89100
10	Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio	Roma	Italy	00100
11	Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza	Roma	Italy	00161
12	Istituto di Ematologia - Università Cattolica	Roma	Italy	00168
13	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