Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and the efficacy of the association of Melphalan/Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MP regimen.

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

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Bortezomib; Melphalan; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

• Patient is relapsed or refractory after one or two lines of treatment including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide- and melphalan-based regimens.

• 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 ≥75 x 109/L without transfusion support within 7 days before the test.

• Absolute neutrophil count (ANC) ≥ 0.75 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:

• Patient has an absolute neutrophil count <0.75 × 109/L within 14 days before enrollment.

• Patient has a calculated or measured creatinine clearance <20 mL/minute within 14 days before enrollment.

• Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.

• Patient has known hypersensitivity to bortezomib, boron, mannitol or thalidomide.