Multiple Myeloma Harbouring the t (4
Conditions
Interventions
Product Name: not applicable
Product Code: PHA-739358
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 827318-97-8
Current Sponsor code: PHA-739358
Other descriptive name: Aurora
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (age = 18 and = 75 years) patients. 2. Confirmed diagnosis of active multiple myeloma that has relapsed or is refractory to at least two previous lines of treatments, including bortezomib and lenalidomide. At least 4 weeks should be elapsed between the end of the last therapy and the entry in the trial. 3. Patients with t (4;14) translocation. 4. Current measurable disease defined by at least one of the following two measurements: · Serum M-protein = 1 g/dl · Urine M-protein = 200 mg/24 h. 5. Prior radiotherapy is allowed provided that no more than 25% of bone marrow reserve has been irradiated and a minimum of 4 weeks have elapsed between the end of prior radiotherapy and the entry into the trial or less if one single lesion had to be irradiated for pain control. 6. ECOG performance status 0-1. 7. Life expectancy of at least 3 months. 8. Resolution of all acute toxic effects (excluding alopecia) of any prior surgery, radiotherapy, radio-surgery or chemotherapy to NCI CTC (Version 3.0) Grade = 1 (exception: stable, grade 2 neuropathy is permitted). 9. Baseline laboratory values fulfilling the following requirements: Absolute Neutrophils Count (ANC) = 1,500/mm3 (= 1.5 x 1000000000/L) Platelets = 75,000/mm3 (= 75 x 1000000000/L) Hemoglobin = 8.0 g/dL Serum Creatinine = 2.0 mg/dL ( = 177 micromol/L) Direct Serum Bilirubin = 1.5 x ULN Liver Transaminases (AST/ALT) = 2.5 x ULN; = 5 x ULN if liver involvement is present. 10. Signed and dated informed consent indicating that the patient is aware of the neoplastic nature of his/her disease and has been informed of the procedures to be followed, the experimental nature of the therapy, potential benefits, side effects, discomforts, risks, and alternative treatments. 11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures. 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: 1. Patients with non-detectable M-component (non-secretory myeloma). 2. Current enrollment in another therapeutic clinical trial. 3. Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to treatment. 4. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, ductal carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years or greater or that poses no immediate clinical threat to the patient. 5. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153) within 8 weeks prior to enrollment. 6. Major surgery, within 4 weeks or not fully recovered prior to Day 1. 7. Pregnancy or breast feeding. Male and female patients sexually active not using an effective form of barrier contraception during the study and in the following 90 days after discontinuation of study treatment. 8. Uncontrolled hypertension with blood pressure exceeding 160/100 mmHg (Stage 2 hypertension according to the JNC 7/ NIH USA 2003 guideline). 9. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis. 10. Cardiac dysrhythmias Grade = 2 according to NCI CTCAE version 3.0. 11. Known active infections, including HIV positive. 12. History of allergic reactions to a similar structural compound, biological agent, or formulation. 13. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the anti-tumor activity of PHA-739358 in patients with Multiple Myeloma (MM) harbouring the t (4;14) translocation.;Secondary Objective: - To define the safety profile of PHA-739358 in MM patients, - To investigate the inhibition of Aurora kinase and FGFR3 signalling in bone marrow plasma cells. ;Primary end point(s): Response rate according to the International Myeloma Working Group uniform response criteria for multiple myeloma. | — |
Countries
France
Outcome results
None listed