Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406978
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2006-11-30
Brief Title:
Melphalan Prednisone Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients
Sponsor:
Silvio Aime
Organization:
University of Turin Italy
Study Overview
Official Title:
A Phase III Multi-Center Open Label Study of Melphalan Prednisone Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPTD
Brief Summary:
This study will evaluate the safety and the efficacy of the association of Melphalan PrednisoneThalidomideDefibrotide MPTD as salvage treatment in advanced and refractory myeloma patients This association might further increase the response rate achieved by oral MPT regimen
Detailed Description:
Defibrotide DF is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects which has been shown to be active in various microangiopathies including the treatment and prophylaxis of veno-occlusive disease While DF has minimal inhibitory effect on multiple myeloma MM in cell isolates it showed single agent activity on human MM xenografts in SCIDNOD mice and markedly increased responsiveness of MM to cytotoxic agents including melphalan cyclophosphamide and dexamethasone in the same models DF might thus enhance the response rate of Melphalan Prednisone and Thalidomide while protecting against the prothrombotic state seen with this combination in the treatment of MM In this multicenter open label non-randomised phase III trial dosing safety and efficacy of melphalan prednisone thalidomide and DF MPTD were determined in pts with relapsedrefractory MM
Primary refractory or pts receiving therapeutic anticoagulation were excluded Oral melphalan was administered at 025 mgKg on D1-4 oral prednisone at 15 mgkg on D 1-4 thalidomide was delivered at 50 mg on D1-35 on cycle 1 and at 100 mg from cycle 2 to cycle 6
Level 1 DF 17 mgKg iv or 24 g po D1-4 followed by 16 g po through D 35 Level 2 DF 34 mgKg iv or 48 g po D 1-4 followed by 32 g po through D 35 Level 3 DF 51 mgKg iv or 72 g po D 1-4 followed by 48 g po through D 35
Each course was repeated every 35d for a total of 6 courses and no DVT prophylaxis was used
Primary refractory or pts receiving therapeutic anticoagulation were excluded Oral melphalan was administered at 025 mgKg on D1-4 oral prednisone at 15 mgkg on D 1-4 thalidomide was delivered at 50 mg on D1-35 on cycle 1 and at 100 mg from cycle 2 to cycle 6
Level 1 DF 17 mgKg iv or 24 g po D1-4 followed by 16 g po through D 35 Level 2 DF 34 mgKg iv or 48 g po D 1-4 followed by 32 g po through D 35 Level 3 DF 51 mgKg iv or 72 g po D 1-4 followed by 48 g po through D 35
Each course was repeated every 35d for a total of 6 courses and no DVT prophylaxis was used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None