Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
Trial Parameters
Brief Summary
This phase 2 study ain to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy. It will enrolled 46 patients (34 in France and 12 in Australia) through 15 sites (11 in France and 4 in Australia).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 2. Histologic diagnosis of AL amyloidosis; 3. Patients should have received at least one line with an alkylating agent and/or a PI, and Dexamethasone and not be in VGPR (or better) at the time of inclusion (patients who did not reach VGPR before, or patients in VGPR or better before but with a hematological relapse at the time of inclusion can be included); 4. Measurable hematologic disease: difference between involved and uninvolved FLC \> 50 mg/L with an abnormal k/l ratio; 5. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system) (See Appendix 1); 6. Wash-out period of at least 4 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies, whichever is longer. 7. Adequate bone marrow function prior to 1st drug intake (C1D1), without transfusion or growth factor support within 5 days prior to 1st drug intake, defined as: * Absolute neutrophils count ≥ 1000/mm3, * Plat