Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma
The purpose of this study is to evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy. This association might further increase the response rate achieved by the standard oral MP regimen.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open Label Study of Oral Melphalan, Prednisone, and CC-5013 (Revlimid) (MPR) as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients|
- SAFETY AND EFFICACY
- PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||January 2008|
In Multiple Myeloma patients, the standard treatment is the oral combination of Melphalan and Prednisone (MP). This approach induces a partial response (PR) rate of approximately 50% and a complete remission (CR) rate of 1-5%, with a median remission duration of 18-20 months and a median overall survival of 3 years.
Recently, the combination of oral MP plus thalidomide increased response rate to 80% and complete remission rate to 20%, marked cytoreduction is the first step toward a sustained remission period.
CC-5013 (Revlimid) is a thalidomide analogue, 50000 times more potent than thalidomide in inhibiting TNF-alfa secretion, a potent growth factor for myeloma cells. Revlimid represents a novel class of anti-cancer drugs, it is active in patients with multiple myeloma who are refractory to conventional and high-dose chemotherapy with a response rate of approximately 30%. The association Revlimid plus dexamethasone further increases the response rate induced by Revlimid by an additional 30%.
This study will evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy. This association might further increase the response rate achieved by the standard oral MP regimen.
In the first part of the study (phase I component), different doses of oral Melphalan (0.18-0.25 mg/Kg) associated with Prednisone (MP) will be combined with escalating doses of Revlimid (from 5 mg/day) and administered together. This phase will define the MTD of the association. In the second part of the study (phase II component), 30 patients will be treated with MPR at dose/s defined from phase I component to verify data of response and toxicity.
|Unità Operativa di Ematologia Trapianto di Cellule Staminali, Casa Sollievo della Sofferenza|
|San Giovanni Rotondo, Foggia, Italy, 71013|
|Unità Operativa di Ematologia, Spedali Civili|
|Brescia, Italy, 25100|
|Reparto di Ematologia, Ospedale Ferrarotto|
|Catania, Italy, 95124|
|Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell’Annunziata, Azienda Ospedaliera Di Cosenza|
|Clinica Ematologica, Ospedale San Martino -Università di Genova|
|Genova, Italy, 16132|
|Cattedra di Ematologia, Dipart. Di Medicina Interna e Scienze Biomediche|
|Parma, Italy, 43100|
|Divisione di Ematologia-Policlinico Umberto I-Università La Sapienza|
|Roma, Italy, 00161|
|Divisione di Ematologia, Azienda Ospedaliera Senese Ospedale A. Sclavo|
|Siena, Italy, 53100|
|Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista|
|Torino, Italy, 10126|
|Principal Investigator:||MARIO BOCCADORO, MD||DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY|
|Study Director:||ANTONIO PALUMBO, MD||DIVISIONE UNIVERSITARIA DI EMATOLOGIA, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY|