Status:
COMPLETED
Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients
Lead Sponsor:
Silvio Aime
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 a...
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 t...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patient is of a legally consenting age as defined by local regulations.
- Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
- Patient was previously diagnosed with multiple myeloma based on standard criteria (see Section 13.2).
- Patient is relapsed after one line of treatment but less than three lines, including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide- and melphalan-based regimens
- Patient with primary refractory disease will be considered not eligible
- Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of \>200 mg/24 hours.
- Patient has a Karnofsky performance status ≥60%.
- Patient has a life-expectancy \>3 months.
- Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):
- Platelet count ≥90 x 109/L without transfusion support within 7 days before the test.
- Absolute neutrophil count (ANC) ≥ 1.00 x 109/L without the use of growth factors
- Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).
- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
- Alanine transaminase (AST): ≤ 2.5 x the ULN.
- Total bilirubin: ≤ 1.5 x the ULN.
- Calculated or measured creatinine clearance: ≥20 mL/minute
Exclusion
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or beast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other concomitant standard/experimental anti-myeloma drug or therapy
- Known positive for HIV or active infectious hepatitis, type B or C
- Other concurrent anticoagulation treatment
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00406978
Start Date
February 1 2006
End Date
April 1 2014
Last Update
May 10 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia
Novara, Novara, Italy, 28100
2
Policlinico Monteluce, Clinica Medica I
Perugia, Perugia, Italy, 06123
3
Divisione Di Ematologia, Ospedali Riuniti
Reggio Calabria, Reggio Calabria, Italy
4
Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova
Reggio Emilia, Reggio Emilia, Italy, 42100