Multiple Myeloma
Conditions
Interventions
Trade Name: REVLIMID (LENALIDOMIDE) 25mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Co
Sponsors
CHU de Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age = 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, 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 -Life expectancy = 3 months -ECOG performance status 0–2 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 46
Exclusion criteria
Exclusion criteria: -Pregnant or lactating females -Evidence of mucosal or internal bleeding and/or platelet refractory -Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment -Known human immunodeficiency virus infection -Active hepatitis viral infection and history of hepatitis B or C -Prior myeloma systemic therapy - Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks. - Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy. - Subjects not eligible for high dose therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This phase II study is designed to determine whether induction and consolidation treatment with 2 x 4 cycles of Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials. The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy ; Secondary Objective: -Determine the safety and tolerability of the drug combination in this patient population as induction and consolidation therapy. -Evaluate the sCR, CR, VGPR and PR rates after induction, HDM with ASCT, consolidation , during and after maintenance -Evaluate the overall response rate, time to response, progression free survival, the overall survival, time to progression and duration of response. -Evaluate the feasibility and quality of the peripheral stem cell collection. ;Primary end point(s): sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation.;Timepoint(s) of evaluation of this end point: sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation.. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Safety and tolerability of the drug combination in this patient population as induction and consolidation therapy. -sCR, CR and VGPR,PR rates after induction, HDM with ASCT, consolidation during and after maintenance -Overall response rate, progression free survival, the overall survival, time to progression and duration of response, time to response. -Feasibility and quality of the peripheral stem cells collection. ; Timepoint(s) of evaluation of this end point: 1-induction and consolidation therapy 2-consolidation during and after maintenance 3-NA 4-Stem cells collection | — |
Countries
France
Contacts
Public ContactMarie Elise Llau
CHU de Toulouse
Outcome results
None listed