Multiple Myeloma relapsing after one previous line therapy MedDRA version: 12.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met: • Clonal bone marrow plasma cells = 10% • Presence of serum and/or urinary monoclonal protein • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: o Hypercalcemia: serum calcium = 11.5 mg/100 ml or o Renal insufficiency: serum creatinine > 1.73 µmol/l o Anemia: normochromic, normocytic with a hemoglobin value of > 2g/100 ml below the lower limit of normal or a hemoglobin value 6 months 7. Man or non-pregnant non-lactating woman, age >18 years and weight > 40 Kg 8. Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. 9. Patient able and willing to comply with study procedures as per protocol 10. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific 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. Patient with peripheral neuropathy Grade >2 2. Patient with hypersensitivity to bortezomib, boron or dexamethazone 3. Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy 4. Patient who received bortezomib within 6 months of randomization to this study 5. Past discontinuation of bortezomib due to associated grade 3 or higher adverse event 6. Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster) 7. Patient with acute diffuse infiltrative pulmonary and pericardial disease 8. Patient treated for a cancer other than multiple myeloma within five years before enrolment, with the exception of basal cell carcinoma and cervical cancer in situ 9. Patient with central nervous system (CNS) metastasis or with history of CNS metastasis 10. Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline) 11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 12. Patient with any condition or concurrent medical events, including any clinically significant deviations from reference ranges in laboratory test, that, according to the physician, could be detrimental to the subjects who participate Previous treatments: 13. High dose of corticosteroids and/or local irradiation should be stopped at least 2 weeks prior to Baseline 14. Administration of any other treatment for multiple myeloma should be stopped at least 4 weeks prior to Baseline. Patients who received bortezomib within 6 months prior to Baseline are excluded 15. Treatment with any investigational agent should be stopped at least 4 weeks prior to Baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to compare the efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib (Velcade®) and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy. Primary endpoint: Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) ; Secondary Objective: Secondary endpoints • Disease progression: - Overall Time to Progression (TTP) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) - Time To Next Treatment (TTNT) • Survival: - Overall Survival (OS) • Response: - Best Response rate during study according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) • Quality of life assessment: - Quality of Life according to the EORTC QLQ-C30 questionnaire at week 12, 24, 36, 48, 60 and 72 - ECOG Performance Status at week 12, 24, 36, 48, 60 and 72 - Karnofsky Performance Status at week 12, 24, 36, 48, 60 and 72 - Bone pain Verbal Rating Score (VRS) at week 12, 24, 36, 48, 60 and 72 - Analgesic (non-opioid) consumption at week 12, 24, 36, 48, 60 and 72 - Opioid consumption at week 12, 24, 36, 48, 60 and 72 • Safety assessments: - Safety profile using the NCI CTC v4.02 classification ;Primary end point(s): Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed