A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
- Conditions
- Multiple Myeloma relapsing after one previous line therapyMedDRA version: 12.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
- Registration Number
- EUCTR2009-017930-35-FR
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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 < 10g/100 ml
o Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
2. Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment
3. Patient with measurable progressive disease defined by at least one of the following two measurements:
• Serum M-protein = 1 g/dL
• Urine M-protein = 200 mg/24h
4. Patient with ECOG = 2
5. Patient with adequate organ function
• Absolute neutrophil count (ANC) = 1.5 giga/L
• Platelets (PTL) = 75 x 109/L
• AST/ALT = 2.5 ULN
• Creatinin clearance = 30 mL/min
• Bilirubin = 1.5 ULN
• Albumin = 0.75 x LLN
• Urea = 1.5 x ULN
• Albuminuria = 300 mg/day
6. Patient with life expectancy > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method