Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis

Inclusion criteria

• ✓. Histologic diagnosis of AL amyloidosis;
• ✓. Patients should have received at least one line(and no more than 3 lines)with an alkylating agent and/or a PIn and dexamethasone and not be in VGPR or CR at the time of inclusion (patients who did not reach VGPR or patients in VGPR or better but with an hematological relapse can be included);
• ✓. Measurable hematologic disease: difference between involved and uninvolved FLC \> 20 mg/L with an abnormal k/l ratio;
• ✓. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system);
• ✓. 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. Treatment from previous therapy should be in accordance to the local clinical practice in which a 4 weeks period is required for the evaluation of response;
• ✓. 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:
• ✓. Adequate organ function defined as:
• ✓. Female patients who are postmenopausal for at least 1 year before the screening visit, or are surgically sterile, or if they are of childbearing potential, agree to practice effective methods of contraception from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to completely abstain from intercourse (serum pregnancy test has to be performed for all women of childbearing potential at the beginning of each cycle during the study. In addition, a pregnancy test may be done at any time during the study at the discretion of the investigator if a subject miss a period or has unusual menstrual bleeding);

Exclusion criteria