Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma
|First Received Date ICMJE||November 2, 2006|
|Last Updated Date||November 29, 2006|
|Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||SAFETY AND EFFICACY|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00396045 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Multiple Myeloma|
|Intervention ICMJE||Drug: Revlimid (CC-5013)|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Italy|
|NCT Number ICMJE||NCT00396045|
|Other Study ID Numbers ICMJE||RV-MM-PI-026, MPR|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Turin, Italy|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Turin, Italy|
|Verification Date||November 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP