RELAPSED / REFRACTORY MULTIPLE MYELOMA PATIENTS MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: SPRYCEL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DASATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-
Trade Name: DELTACOR
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age ≥ 18 years and ≤75 year - 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 plasmocytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan). - Patient is relapsed or refractory and has received previous regimen containing Thalidomide or Lenalidomide and Bortezomib or even MP (patient is refractory if there is a progression during the last therapy or within 2 months after its completion). - Patient has ≤ Grade 2 peripheral neuropathy within 28 days before enrollment and all acute toxicities from any prior therapy (radiotherapy, chemotherapy or surgical procedures) must have resolved to grade ≤ 2, according to the NCI CTCAE version 3.0 at study entry. - Patient has the following laboratory values within 28 days before Baseline day 1 of the Cycle 1: - Total bilirubin Lower Limit of Normal (LLN) - Calculated or measured creatinine clearance: ≥ 20 mL/minute - Hemoglobin, Neutrophil count, Platelets, PT, PTT, Fibrinogen all Grade 0-1 - Corrected serum calcium ≤ 14 mg/dL ( ≤ 3.5 mmol/L). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: - Patients with > 2 previous treatment regimens. - Multiple Myeloma treatment (ie, chemotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) administered within 21 days prior to treatment initiation. - Use of any other concomitant standard/experimental anti-myeloma drug or therapy - Concurrent anticoagulation treatment or medications that directly or durably inhibit platelet function. - Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 year. Exceptions: basal cell or non metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix. -Concurrent medical condition which may increase the risk of toxicity, including: - Pleural or pericardial effusion of any grade - Clinically significant cardiac disease (NYHA classification III and IV);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the combination of dasatinib with melphalan and prednisone provides therapeutic benefits and is safe in patients with relapsed/refractory Multiple Myeloma.;Secondary Objective: Progression-free survival and overall survival.;Primary end point(s): To determine whether the combination of dasatinib with melphalan and prednisone provides therapeutic benefits and is safe in patients with relapsed/refractory Multiple Myeloma. | — |
Countries
Italy
Outcome results
None listed