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

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00358020
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed Description

In Multiple Myeloma (MM) patients, the conventional treatment is the oral combination melphalan and prednisone (MP). thalidomide has been widely used in myeloma, it has been proved clinical effective in refractory myeloma patients, it acts sinergistically in association with dexamethasone. In newly diagnosed patients, the combination oral MP plus thalidomide increased the partial and complete response rate.Bortezomib represents a novel class of anti-cancer drugs, it is active in patient with multiple myeloma who are refractory to conventional chemotherapy. In a preliminary report, the combination of VELCADE and Thalidomide induced a remarkable 60% PR rate in advanced refractory myeloma patients. This study will 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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-28
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-30
• Last Update Posted: 2006-12-04
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SAFETY AND EFFICACY

Secondary Outcome Measures

Name	Time	Method
PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Trial Locations

Locations (7)

Divisione Di Ematologia, Ospedali Riuniti; 🇮🇹 Reggio Calabria, Italy

Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello; 🇮🇹 Palermo, Italy

Cattedra E Divisione Di Ematologia, Università Tor Vergata, Ospedale S.Eugenio; 🇮🇹 Roma, Italy

Divisione Di Ematologia, Ospedale Centrale; 🇮🇹 Bolzano, Italy

Divisione Universitaria Ematologia - Az.Osp. San Giovanni Battista; 🇮🇹 Torino, Italy

Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza; 🇮🇹 Cosenza, Italy

Ematologia, Azienda Ospedaliera S.Giovanni Battista; 🇮🇹 Torino, Italy