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

Soochow University

Status: Not yet enrolling

Conditions: Newly Diagnosed Multiple Myeloma

Treatments: Drug: Daratumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05088330

D-VRD-MM05

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 years and ≤ 70 years, male or female；

2. Newly diagnosed multiple myeloma (NDMM) ；

3. Transplant-eligible；

4. Non-17p-, t(4;14) , t(14;16)；

5. Expected survival ≥12 weeks;

6. Eastern Cooperative Oncology Group (ECOG) scores 0 - 2.

7. Subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments):

   1. 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.
   2. 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);

8. Normal cardiopulmonary function;

9. The patient agrees to join the clinical trial and signs an informed consent form.

Exclusion Criteria

1. Poor hypertension control;

2. Have received ASCT or anti-tumor systemic therapy;

3. Peripheral neuropathy or neuralgia of grade 2 or higher;

4. During pregnancy or lactation or planning to become pregnant;

5. History of other malignant tumors within 5 years;

6. 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.

7. Participating in other clinical trials;

8. Allergic to the drugs in the treatment plan;

9. Receiving any other experimental drugs or experimental medical devices;

10. The investigator believes that the patient has other conditions that are not suitable for participating in this study.

11. Patients with R-ISS Phase III

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

D-VRD

Experimental group

Description:

treatment with D-VRD in NDMM

Treatment:

Drug: Daratumumab