OncoMatch/Clinical Trials/NCT06762769
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
Is NCT06762769 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Isatuximab and Iberdomide for smouldering myeloma.
Treatment: Isatuximab · Iberdomide · Dexamethasone — The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma. The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: IGH t(4;14)
Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies
Allowed: IGH t(14;16)
Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies
Allowed: TP53 deletion 17p
Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies
Allowed: RB1 deletion 13q
Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies
Allowed: CKS1B 1q gain
Presence of t(4;14), t(14;16), del 17p, del 13q or 1q gain by fluorescence in situ hybridization (FISH) studies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: myeloma therapy
Received previous treatment for myeloma, smouldering myeloma or solitary plasmacytoma
Cannot have received: standard anti-cancer radiotherapy/chemotherapy/targeted therapy including investigational therapy
Exception: within 4 weeks prior to registration
Treatment with any other standard anti-cancer radiotherapy/chemotherapy/targeted therapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks prior to registration
Lab requirements
Blood counts
Neutrophils ≥1.0 x10^9/L (unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥0.75 x 10^9/L is allowed), Haemoglobin (Hb) ≥ 100g/L, Platelets ≥ 75 ×10^9/L
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/minute, according to the Cockcroft-Gault formula, following correction of reversible causes
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN); ALT and/or AST ≤ 3 x ULN (if ALT and AST are tested, both must meet this criteria)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x ULN; Neutrophils ≥1.0 x10^9/L (unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥0.75 x 10^9/L is allowed), Haemoglobin (Hb) ≥ 100g/L, Platelets ≥ 75 ×10^9/L; Creatinine clearance (CrCl) ≥ 30 mL/minute, according to the Cockcroft-Gault formula, following correction of reversible causes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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