A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

Study Overview
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Brief Summary
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This is an open-label, single arm study to access the effect of treatment with D-VRD in patients with newly diagnosed standard risk multiple myeloma.

Detailed Description
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Research object:Newly diagnosed standard-risk multiple myeloma (NDMM) diagnosed according to the International Myeloma Working Group (IMWG) standards and who have been assessed to receive Autologous Stem Cell Transplantation (ASCT) but actively refused.Objective: To explore the therapeutic options of daratumamab (D) combined with bortezomib (V), lenalidomide (R) and dexamethasone ( d) for objective assessment of patients who can receive ASCT but not to receive transplantation.Main indicators:negative rate of minimal residual disease (MRD) upon completion of cycle 8 (24 weeks).

Official Title
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A Prospective Study of Daratumumab Combined With VRD in the Treatment of Patients With Newly Diagnosed Standard-risk Multiple Myeloma : a Single-center, Single-arm Clinical Study

Conditions
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Newly Diagnosed Multiple Myeloma

Intervention / Treatment
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* Drug: Daratumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age ≥ 18 years and ≤ 70 years, male or female； Newly diagnosed multiple myeloma (NDMM) ； Transplant-eligible； Non-17p-, t(4;14) , t(14;16)； Expected survival ≥12 weeks; Eastern Cooperative Oncology Group (ECOG) scores 0 - 2. Subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments): Complete blood count (CBC) results: absolute neutrophil count（ANC） ≥ 1.0 × 109/L, platelet count ≥ 75 × 109/L (if the proportion of plasma cells in the bone marrow is > 50%, subjects with platelets ≥ 50 × 109/L will be eligible), Hb ≥ 70 g/L. Blood biochemistry: creatinine clearance ≥ 30 mL/min, alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN)，aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN. Serum calcium ≤14.0 mg/dL (≤3.5 mmol/L); Normal cardiopulmonary function; The patient agrees to join the clinical trial and signs an informed consent form. Exclusion Criteria Poor hypertension control; Have received ASCT or anti-tumor systemic therapy; Peripheral neuropathy or neuralgia of grade 2 or higher; During pregnancy or lactation or planning to become pregnant; History of other malignant tumors within 5 years; Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA. Participating in other clinical trials; Allergic to the drugs in the treatment plan; Receiving any other experimental drugs or experimental medical devices; The investigator believes that the patient has other conditions that are not suitable for participating in this study. Patients with R-ISS Phase III -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: D-VRD
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-VRD<br>treatment with D-VRD in NDMM | Drug: Daratumumab<br>* treatment with D-VRD in NDMM<br>* Other names: DARA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of minimal residual disease negativity | rate of minimal residual disease negativity | end of 8 cycles |