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

NCT05088330 | Unknown

• 1 other identifier: D-VRD-MM05
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• rate of minimal residual disease negativity

  rate of minimal residual disease negativity

  end of 8 cycles

Study Arms (1)

D-VRD

EXPERIMENTAL

treatment with D-VRD in NDMM

Drug: Daratumumab

Interventions

Daratumumab DRUG

treatment with D-VRD in NDMM

Also known as: DARA

D-VRD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Interventions

daratumumab

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: D-VRD

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 21, 2021
• Study Start: December 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 31, 2024
• Last Updated: October 21, 2021

Record last verified: 2021-10