OncoMatch/Clinical Trials/NCT06409702
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
Is NCT06409702 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments for newly diagnosed.
Treatment: Carfilzomib · Daratumumab · Lenalidomide · Dexamethasone · VRD for first-cycle induction therapy — The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: IGH t(4;14)
high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined
Required: IGH t(14;16)
high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined
Required: IGH t(14;20)
high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and/or TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined
Required: TP53 deletion
Del(17p) or -17 and/or TP53 mutation
Required: TP53 mutation
Del(17p) or -17 and/or TP53 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
neutrophils ≥ 1.0 x 10^9 /L, platelets ≥ 70 x 10^9 /L (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 10^9 /L)
Kidney function
serum creatinine clearance ≥ 40mL/min
Liver function
AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value
bone marrow function: neutrophils ≥ 1.0 x 10^9 /L, platelets ≥ 70 x 10^9 /L (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 10^9 /L); AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value; serum creatinine clearance ≥ 40mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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