OncoMatch/Clinical Trials/NCT06158269
DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
Is NCT06158269 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies DVRd for multiple myeloma.
Treatment: DVRd — Evaluate the efficacy of DVRd in patients with newly diagnosed double-hit multiple myeloma (MM) and the feasibility of minimal residual disease (MRD) guided maintenance therapy
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: IGH t(4;14)
At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
Required: IGH t(14;16)
At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
Required: IGH t(14;20)
At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
Required: TP53 deletion (del(17p))
At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
Required: CKS1B gain/amp(1q)
At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-myeloma chemotherapy
Subjects had not received any anti-MM chemotherapy
Cannot have received: extensive pelvic irradiation (more than half of the pelvic area)
extensive pelvic irradiation (more than half of the pelvic area)
Cannot have received: anti-myeloma glucocorticoids
Exception: glucocorticoids for no more than 14 days to control symptoms
anti-MM glucocorticoids, except those who used glucocorticoids for no more than 14 days to control symptoms
Lab requirements
Blood counts
WBC count ≥ 1.5×10^9/L, absolute neutrophil count ≥ 1.0×10^9/L, hemoglobin ≥ 75 g/L, and platelet count ≥ 75×10^9/L (if bone marrow plasmacytes < 50%) or platelet count ≥ 50×10^9/L (if bone marrow plasmacytes ≥ 50%).
Kidney function
Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas).
Liver function
Total bilirubin < 1.5 × ULN (total bilirubin in patients with Gilbert's syndrome can be restricted to <3 × ULN), and AST and ALT ≤ 2.5 × ULN.
Total bilirubin < 1.5 × ULN (total bilirubin in patients with Gilbert's syndrome can be restricted to <3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. Creatinine clearance rate ≥ 30 mL/min (calculated by cockcroft and Gault formulas). Routine blood test within 7 days before the first day of cycle 1 meets the following criteria: white blood cell (WBC) count ≥ 1.5×10^9/L, absolute neutrophil count ≥ 1.0×10^9/L, hemoglobin ≥ 75 g/L, and platelet count ≥ 75×10^9/L (if bone marrow plasmacytes < 50%) or platelet count ≥ 50×10^9/L (if bone marrow plasmacytes ≥ 50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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