OncoMatch/Clinical Trials/NCT06140966

Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

Is NCT06140966 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for multiple myeloma.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT06140966Data as of May 2026

Treatment: Daratumumab · Carfilzomib · Lenalidomide · Dexamethasone · Cisplatin · epirubicin · Cyclophosphamide · Etoposide · Melphalan · bortezomib — This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: WHSC1 t(4;14)

t(4;14)

Required: MAF t(14;16)

t(14;16)

Required: MAFB t(14;20)

t(14;20)

Required: CKS1B 1q21+

1q21+

Required: TP53 deletion

del(17p)

Required: TP53 mutation

p53 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic therapy for multiple myeloma

Exception: Prior bisphosphonates and localized radiation are allowed.

Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.

Lab requirements

Blood counts

Platelet count ≥ 50,000/μL, absolute neutrophil count ≥ 1000/μL, haemoglobin ≥ 60 g/L before induction chemotherapy

Kidney function

Calculated creatinine clearance ≥ 30 mL/min

Liver function

ALT or AST ≤ 3x ULN; Bilirubin ≤ 2x ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤ 2.0x ULN)

Cardiac function

Ejection fraction by echocardiogram (ECHO) ≥ 45%

Platelet count < 50,000/μL, absolute neutrophil count <1000/μL, and haemoglobin <60 g/L before induction chemotherapy. Calculated creatinine clearance <30 mL/min, alanine transaminase (ALT) or aspertate aminotransferase (AST) >3 times upper limit of normal (ULN). Bilirubin >2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin >2.0 times ULN). Ejection fraction by echocardiogram (ECHO) ≥ 45%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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