Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients (MPTD)

This is an interventional treatment trial for Multiple Myeloma focused on measuring MYELOMA, THALIDOMIDE, DEFIBRODITE Read More

Inclusion Criteria:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 Criteria:

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