OncoMatch/Clinical Trials/NCT06216158
Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
Is NCT06216158 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Iberdomide and Isatuximab for multiple myeloma.
Treatment: Iberdomide · Isatuximab · Dexamethasone — The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Patients with newly-diagnosed multiple myeloma who underwent a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT can also be recruited. The main question it aims to answer is: • Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
WHO 0–2
Prior therapy
Must have received: proteasome inhibitor (bortezomib) — induction/consolidation
Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) [e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalidomide and dexamethasone] with an anti-CD38 monoclonal antibody (isatuximab or daratumumab)
Must have received: immunomodulatory drug (thalidomide, lenalidomide) — induction/consolidation
Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) [e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalidomide and dexamethasone] with an anti-CD38 monoclonal antibody (isatuximab or daratumumab)
Must have received: anti-CD38 monoclonal antibody (isatuximab, daratumumab) — induction/consolidation
Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) [e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalidomide and dexamethasone] with an anti-CD38 monoclonal antibody (isatuximab or daratumumab)
Must have received: high dose melphalan therapy (melphalan) — pre-ASCT
Received at least one cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT)
Must have received: autologous stem cell transplant — post-induction
Received at least one cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT)
Cannot have received: systemic anti-myeloma treatment
Exception: other than administered within the GMMG-HD8 / DSMM XIX trial or other than defined in the inclusion criteria above (including up to two cycles cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT))
Previous systemic anti-myeloma treatment other than administered within the GMMG-HD8 / DSMM XIX trial or other than defined in the inclusion criteria above (including up to two cycles cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT). Local, consolidative radiotherapy for myeloma disease is permitted unless performed in case of progressive disease according to IMWG criteria
Lab requirements
Blood counts
Platelet count < 75 x 10^9/l; Haemoglobin ≤ 8.0 g/dl, unless related to MM; Absolute neutrophil count (ANC) < 1.0 x 10^9/l (the use of colony stimulating factors within 14 days before the test is not allowed); Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)
Kidney function
Severe renal insufficiency (Creatinine Clearance < 30ml/min) or requiring hemodialysis
Liver function
Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to MM or HDM/ASCT.
Cardiac function
Severe cardiac dysfunction (NYHA classification III-IV)
Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to MM or HDM/ASCT. Severe renal insufficiency (Creatinine Clearance < 30ml/min) or requiring hemodialysis. Platelet count < 75 x 10^9/l. Haemoglobin ≤ 8.0 g/dl, unless related to MM. Absolute neutrophil count (ANC) < 1.0 x 10^9/l (the use of colony stimulating factors within 14 days before the test is not allowed). Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l). Severe cardiac dysfunction (NYHA classification III-IV).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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