Status:
COMPLETED
Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Lead Sponsor:
University of Turin, Italy
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patie...
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 ...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00358020
Start Date
November 1 2004
End Date
December 1 2008
Last Update
December 4 2006
Active Locations (7)
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1
Divisione Di Ematologia, Ospedale Centrale
Bolzano, BOLZANO, Italy
2
Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza
Cosenza, COSENZA, Italy
3
Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello
Palermo, PALERMO, Italy
4
Divisione Di Ematologia, Ospedali Riuniti
Reggio Calabria, Reggio Calabria, Italy