Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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14 April 2020 |
Main ID: |
EUCTR2009-017930-35-AT |
Date of registration:
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02/08/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to compare masitinib in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma
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Scientific title:
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A prospective, multicentre, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 6 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
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Date of first enrolment:
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08/09/2011 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017930-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Greece
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Hungary
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Italy
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Korea, Republic of
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Project Manager
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Address:
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3 avenue George V
75008
Paris
France |
Telephone:
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0033147207635 |
Email:
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cecile.artus-arduise@ab-science.com |
Affiliation:
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AB Science |
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Name:
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Clinical Project Manager
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Address:
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3 avenue George V
75008
Paris
France |
Telephone:
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0033147207635 |
Email:
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cecile.artus-arduise@ab-science.com |
Affiliation:
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AB Science |
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Key inclusion & exclusion criteria
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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 > 173 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) (defined in Table 5) to one previous line of treatment (defined in Table 6). Patients previously treated with Bortezomib for multiple myeloma can be included if and only if: - they have shown minimal, partial or complete response to this treatment - they have not been refractory to this treatment (to be considered as bortezomib refractory patient, any patient who didn't show any response to previous bortezomib treatment or whose disease progressed during or within 60 days of bortezomib treatment) 3. Patient candidate for receiving the standard therapy (bortezomib and dexamethazone) 4. 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 5. Patient with ECOG = 2 6. Patient with adequate organ function • Absolute neutrophil count (ANC) = 1.5 x 109/L • Haemoglobin = 10 g/dL • Platelets (PTL) = 75 x 109/L • AST/ALT = 3x ULN (= 5 x ULN in case of liver metastases) • Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases) • Creatinin clearance = 30 mL/min (Cockcroft and Gault formula) • Bilirubin = 1.5 ULN (= 3 x ULN in case of liver metastases) • Albuminaemia = 1 LLN • Urea = 2 x ULN • Albuminuria = 300 mg/24 hours 7. Patient with life expectancy > 6 months 8. Man or non-pregnant non-lactating woman, age >18 years and weight > 40 Kg and BMI > 18 kg/m2 9. 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. 10. Patient able and willing to comply with study procedures as per protocol 11. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent. 12. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
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 one of the following cardiac conditions: •Patient with recent cardiac history (within 6 months) of: -Acute coronary syndrome -Acute heart failure (class III or IV of the NYHA classification) -Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) •Patient with cardiac failure class III or IV of the NYHA classification •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) •Syncope without known aetiology within 3 months •Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 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
Previous treatments: 1. High dose of corticosteroids and/or local irradiation should be stopped at least 2 weeks prior to Baseline 2. 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 3. Treatment with any investigational agent should be stopped at least 4 weeks prior to Baseline 4. Patient eligible for bone-marrow transplantation as second line therapy
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Multiple Myeloma relapsing after one previous line therapy MedDRA version: 21.0
Level: LLT
Classification code 10028228
Term: Multiple myeloma
System Organ Class: 100000004864
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Intervention(s)
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Product Name: masitinib Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: masitinib Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: date of documented progression or death during the study
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Main Objective: The objective is to compare the efficacy and safety of masitinib 6 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 have received one previous therapy.
Primary endpoint: Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria)
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Primary end point(s): Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria)
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Secondary Objective: Secondary endpoints • Disease progression: - Overall Time to Progression according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) - Time To Next Treatment • Survival: - Overall Survival • Response: - Best Response rate during study according to International Myeloma Working Group criteria 2009 (revised Bladé criteria) • Quality of life assessment: - Quality of Life according to the EORTC QLQ-C30 questionnaire at week 0 (baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 - ECOG Performance Status at week 0 (screening),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 - Bone pain Verbal Rating Score (VRS) at week 0 (baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 - Analgesic (non-opioid) consumption at week 0 (baseline),3,6,9, 12,15,18,21,24,32,40,48,56,64 and 72 - Opioid consumption at week 0 (baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 • Safety assessments: - Safety profile using the NCI CTC v4.02 classification
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Secondary Outcome(s)
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Secondary end point(s): •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 0 (baseline), 3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 -ECOG Performance Status at week 0 (screening),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 -Bone pain Verbal Rating Score (VRS) at week 0 (baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 -Analgesic (non-opioid) consumption at week 0 (baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 -Opioid consumption at week 0(baseline),3,6,9,12,15,18,21,24,32,40,48,56,64 and 72 •Safety assessments: -Safety profile using the NCI CTC v4.02 classification (including adverse events, laboratory values, vital signs and physical examination including ECG).
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Timepoint(s) of evaluation of this end point: TTP: date of documented progression; TTNT: date of initiation of a new line of treatment due to progression; OS; documented death; QOL: see paragraph above
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Secondary ID(s)
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2009-017930-35-FR
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AB06002
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Source(s) of Monetary Support
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AB Science
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Ethics review
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Status: Approved
Approval date: 21/07/2011
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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