Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 association might further increase the response rate achieved by oral MPT regimen

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silvio Aime
• Treatments: Defibrotide; Melphalan; Prednisone; Thalidomide

Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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