Multiple Myeloma newly diagnosed MedDRA version: 18.0 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid 25 mg (Lenalidomide)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
CHU de Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patients = 18 years and = 65 years at the time of signing informed consent form - Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group Diagnostic Criteria for plasma cells disorders (leukemia 2009) -Subjects must have symptomatic myeloma with CRAB criteria - Subjects must have measurable disease requiring systemic therapy defined by serum M-component = 5g/l or urine M-component = 200 mg/24h or serum FLC = 100 mg/l. -Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy). Two weeks must have elapsed since the date of the last radiotherapy treatment -Subjects must be eligible for high dose therapy. -Life expectancy = 3 months 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: -Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test -Evidence of mucosal or internal bleeding and/or platelet refractory. -Prior myeloma systemic therapy -Central nervous system involvement -Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug= -Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug. -Evidence of current uncontrolled cardiovascular conditions... -Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2, strong inhibitors of CYP3A or strong CYP3A inducers or use of Ginkgo biloba or St. John’s wort -Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis. -Diagnosed or treated for another malignancy within 5 years before study enrollment -Patient has significant neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the sCR rate of the combination of Ixazomib, Lenalidomide with and without dexamethasone as induction and extended consolidation therapy in an intensive program in newly diagnosed MM patients, after consolidation and before maintenance therapy.;Secondary Objective: Determine the safety and tolerability of the drug combination in this patient population as induction and extensive consolidation therapy. Evaluate the sCR, CR, VGPR and PR rates, the overall response rate after induction, high dose Melphalan, early consolidation, late consolidation and maintenance therapy Evaluate progression free survival, overall survival, time to progression and duration of response, time to response. Evaluate the quality of stem cell harvest after induction therapy Determine biological prognostic factors influencing outcome and response rates ;Primary end point(s): The sCR rate ;Timepoint(s) of evaluation of this end point: After consolidation and before maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-the safety and tolerability 2-the sCR, CR, VGPR and PR rates, the overall response rate 3-évaluate progression free survival, overall survival, time to progression and duration of response, time to response 4-the quality of stem cell harvest 5-biological prognostic factors influencing outcome and response rates;Timepoint(s) of evaluation of this end point: 1-induction and consolidation 2-after induction, high dose Melphalan, early consolidation, late consolidation and maintenance therapy 3-end of study 4-after stem celsl harvest 5-end of study | — |
Countries
France
Contacts
Public ContactHuguet
CHU TOULOUSE
Outcome results
None listed