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OncoMatch/Clinical Trials/NCT06158269

DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma

Is NCT06158269 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies DVRd for multiple myeloma.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT06158269Data as of Jun 2026Location: China

Treatment: DVRdEvaluate 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

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Extracted eligibility criteria

Treatments studied

Other

DVRd

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)

Demographics

Ages ≤ 70

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06158269 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require IGH?

Yes, IGH t(4;14) is a required biomarker for enrollment.

Does this trial require IGH?

Yes, IGH t(14;16) is a required biomarker for enrollment.

Does this trial require IGH?

Yes, IGH t(14;20) is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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