Multiple Myeloma Clinical Trial
Official title:
A Phase I/II, Multi-Center, Open Label Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients
This study will evaluate the safety and the efficacy of the association of Melphalan/ Prednisone/Thalidomide/Defibrotide (MPTD) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by oral MPT regimen
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 SCID/NOD 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 I/II trial,
dosing safety and efficacy of melphalan, prednisone, thalidomide, and DF (MPTD) were
determined in pts with relapsed/refractory MM.
Primary refractory or pts receiving therapeutic anticoagulation were excluded. Oral
melphalan was administered at 0,25 mg/Kg on D1-4, oral prednisone at 1,5 mg/kg 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 mg/Kg i.v. or 2.4 g p.o. D1-4, followed by 1.6 g p.o. through D 35 Level +
2 DF = 34 mg/Kg i.v. or 4.8 g p.o. D 1-4, followed by 3.2 g p.o. through D 35 Level + 3 DF =
51 mg/Kg i.v. or 7.2 g p.o. D 1-4, followed by 4.8 g p.o. through D 35.
Each course was repeated every 35d for a total of 6 courses and no DVT prophylaxis was used.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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