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

Newly Diagnosed Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05088330
• Other study ID #: D-VRD-MM05
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Drug:
• Daratumumab
treatment with D-VRD in NDMM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of minimal residual disease negativity	rate of minimal residual disease negativity	end of 8 cycles