Multiple Myeloma Clinical Trial
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
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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