NCT06158269 DVRd in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma
| NCT ID | NCT06158269 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily signing the Informed Consent Form (ICF). 2. Age: ≥ 18 years old and \< 70 years old. 3. Newly diagnosed MM according to International Myeloma Working Group (IMWG) criteria, with at least one measurable disease: The serum M protein detected by serum protein electrophoresis (SPEP) is ≥ 1g/dL (≥ 10 g/L), or if it is immunoglobulin A (IgA) or immunoglobulin D (IgD) subtype, quantitative levels of total IgA or IgD can be used as a substitute; Or urine M-protein level ≥ 200 mg/24 h; Or if only the serum free light chain (FLC) ratio is abnormal, the affected serum FLC ≥ 100 mg/L (normal FLC ratio: 0.26 to 1.65). 4. At least two high-risk cytogenetic abnormalities: t(4;14), t(14;16), t(14;20), del(17p), gain/amp(1q) (the threshold for copy number variation is 20%, and the threshold for translocation is 10%. 5. The Eastern Cooperative Oncology Group (ECOG) score is 0, 1, or 2 points. The ECOG score of 3 points due to myeloma bone disease can be included. 6. Su