Treatment of patients with relapsed or refractory multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: DELTACORTENE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Prednisone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: ALKERAN
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient is of a legally consenting age as defined by local regulations. -Age ≥ 18 years -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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 symptomatic MM based on standard criteria, and has measurable disease, defined as follows: Secretory myeloma: 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; Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan). -Patient is relapsed or refractory after one or two lines of treatment including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide, VELCADE 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) ≥ 1.000 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether the association of VMP (with Melphalan at dose of 24 mg/28 days and Velcade 1.3 mg/m2, weekly) is safe and induces a significant rate of PR in patients with relapse/refractory myeloma.;Secondary Objective: Determine the PFS Determine the OS.;Primary end point(s): Determine whether the association of VMP (with Melphalan at dose of 24 mg/28 days and Velcade 1.3 mg/m2, weekly) is safe and induces a significant rate of PR in patients with relapse/refractory myeloma. | — |
Countries
Italy
Outcome results
None listed