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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05088330

Enrollment

Registered

2021-10-21

Start date

2021-12-01

Completion date

2024-12-31

Last updated

2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Multiple Myeloma

Brief summary

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

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).

Interventions

DRUGDaratumumab

treatment with D-VRD in NDMM

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

D-VRD

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame	Description
rate of minimal residual disease negativity	end of 8 cycles	rate of minimal residual disease negativity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026