OncoMatch/Clinical Trials/NCT05066607
Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
Is NCT05066607 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Isatuximab for al amyloidosis.
Treatment: Isatuximab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Disease stage
Excluded: Stage CARDIAC STAGE IIIB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: alkylating agent
Patients should have received at least one line with an alkylating agent and/or a PI, and Dexamethasone
Must have received: proteasome inhibitor
Patients should have received at least one line with an alkylating agent and/or a PI, and Dexamethasone
Must have received: Dexamethasone (dexamethasone)
Patients should have received at least one line with an alkylating agent and/or a PI, and Dexamethasone
Cannot have received: anti-CD38 therapy
Previous anti-CD38 therapy
Cannot have received: Pomalidomide (pomalidomide)
Exception: if refractory to Pomalidomide
Previous Pomalidomide therapy (if refractory to Pomalidomide)
Lab requirements
Blood counts
Absolute neutrophils count ≥ 1000/mm3, Platelets ≥ 75000/mm3, Hemoglobin ≥ 8.0 g/dL
Liver function
Serum ASAT or ALAT ≤ 3.0 X ULN; Serum total bilirubin level < 1.5 x ULN, unless for subjects with Gilbert's syndrome where the direct bilirubin should then be ≤ 2.0 x ULN
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, Platelets ≥ 75000/mm3, Hemoglobin ≥ 8.0 g/dL; Adequate organ function defined as: Serum ASAT or ALAT ≤ 3.0 X ULN; Serum total bilirubin level < 1.5 x ULN, unless for subjects with Gilbert's syndrome where the direct bilirubin should then be ≤ 2.0 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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