MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Pomalidomide
Product Name: Pomalidomide
Product Code: Pomalidomide
Pharmaceutical Form: Capsule
Trade Name: Carfilzomib
Product Name: Carfilzomib
Product Code: Carfilzomib
Pharmaceutical
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age 18 years or older - Life expectancy of > 6 months. - Must be in R1 (Line 2) and R2 (Line 3) relapse Multiple Myeloma with a measurable disease o Have had 1 to maximum 2 lines of therapy prior to study entry o Relapse Refractory or primary refractory or relapse o Must have received prior treatment with a Lenalidomide-containing regimen for at least 2 consecutive cycles - Must have measurable disease as defined by the following: must have a clearly detectable and quantifiable monoclonal M-component value in the serum and/or urine. o IgG/IgA (serum M-component > 5g/l), o Light chain (serum M-component >1g/l or Bence Jones > 200mg/24H), o Serum FLC assay (including for IgD isotypes): involved FLC level > 10 mg/dl provided serum. FLC ratio is abnormal for patients not measurable on any of the 3 above criteria. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 - Wash out period without MM treatment must be of 28 days minimum before C1D1, except for anti CD-38 - Adequate bone marrow function, documented within 72 hours and without transfusion 72 hours prior to the first intake of investigational product (C1J1) with no growth factor support (one week), defined as: o Absolute neutrophils = 1 x109/L, o Untransfused Platelet count = 75 x109/L, o Hemoglobine = 8.5 g/dL. -Adequate organ function defined as: o Serum total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation. - Known positive for HIV or active infectious hepatitis, type B or C. - Patients with non-secretory MM and non-measurable MM - Patient with terminal renal failure that require dialysis or clairance creatinine 2 severity - Pregnant or breast-feeding females - Refusal to participate in the study - Persons protected by a legal regime (guardianship, trusteeship) - Participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of Isatuximab, Pomalidomide plus Carfilzomib in early Relapse Refractory Multiple Myleoma according to IMWG*.;Secondary Objective: - To assess the safety according to CTCAE 5.0. - To assess response to the treatment according to IMWG*. - To assess the survival according to IMWG*. ;Primary end point(s): MRD 10-5 incidence rate determined at any time point in patients that reached at least VGPR with IsPd +K as per IMWG criteria by NGS ;Timepoint(s) of evaluation of this end point: At any time point during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Treatment emergent adverse events of Isatuximab, Pomalidomide plus Carfilzomib will be evaluated according to CTCAE 5.0. 2)To determine Overall Response Rate (ORR, Partial Response and better), Very Good Partial Response (VGPR) + CR rate of IsPd +K as per IMWG criteria and with M protein interference testing. Clinical benefit response rate (CBR, Minor Response (MR) and better) of IsPd +K as per IMWG criteria. 3)Time to response and Response duration for responders as per IMWG criteria. 4)Overall Survival (OS), Progression free survival (PFS), Time To Progression (TTP), Time To Next Therapy (TTNT) and Event Free survival (EFS) of IsPd +K will be evaluated as per IMWG criteria. ;Timepoint(s) of evaluation of this end point: At any time point during treatment | — |
Countries
France
Contacts
Public ContactABRIAT Fanny
CHU de Poitiers
Outcome results
None listed