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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Gruppo Italiano per lo Studio del Mieloma Multiplo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Thalidomide, Diagnosis, Elderly patients

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Divisionedi Ematologia - Ospedali Riuniti
  • Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
  • Divisione di Ematologia - Az. Osp. S.Croce Carle
  • U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
  • Ematologia - H.S. Gerardo
  • Cattedra e Divisione di Ematologia Università Federico II
  • Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello
  • Clinica Medica I, Policlinico Monteluce
  • Divisione di Ematologia Ospedali Riuniti
  • Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio
  • Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza
  • Istituto di Ematologia - Università Cattolica
  • Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista

Outcomes

Primary Outcome Measures

Response Rate
Progression Free Survival
Event Free Survival

Secondary Outcome Measures

Safety
Overall Survival

Full Information

First Posted
October 4, 2005
Last Updated
August 1, 2018
Sponsor
Gruppo Italiano per lo Studio del Mieloma Multiplo
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1. Study Identification

Unique Protocol Identification Number
NCT00232934
Brief Title
Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2002 (Actual)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano per lo Studio del Mieloma Multiplo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Thalidomide, Diagnosis, Elderly patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
Response Rate
Title
Progression Free Survival
Title
Event Free Survival
Secondary Outcome Measure Information:
Title
Safety
Title
Overall Survival

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Boccadoro, MD
Organizational Affiliation
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Palumbo, MD
Organizational Affiliation
Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Divisionedi Ematologia - Ospedali Riuniti
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Divisione di Ematologia - Az. Osp. S.Croce Carle
City
Cuneo
ZIP/Postal Code
26100
Country
Italy
Facility Name
U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
City
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ematologia - H.S. Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Cattedra e Divisione di Ematologia Università Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Clinica Medica I, Policlinico Monteluce
City
Perugia
ZIP/Postal Code
06123
Country
Italy
Facility Name
Divisione di Ematologia Ospedali Riuniti
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto di Ematologia - Università Cattolica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
10091392
Citation
San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58.
Results Reference
background
PubMed Identifier
10564685
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. doi: 10.1056/NEJM199911183412102. Erratum In: N Engl J Med 2000 Feb 3;342(5):364.
Results Reference
background
PubMed Identifier
11049970
Citation
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.
Results Reference
background
PubMed Identifier
21228328
Citation
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, Omede 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. doi: 10.1182/blood-2010-09-307645. Epub 2011 Jan 12.
Results Reference
derived
PubMed Identifier
18505783
Citation
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. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.
Results Reference
derived
PubMed Identifier
16530576
Citation
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. doi: 10.1016/S0140-6736(06)68338-4.
Results Reference
derived

Learn more about this trial

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

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