Back to resultsA Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM
Primary Purpose
Newly Diagnosed Multiple Myeloma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daratumumab
Sponsored by
About this trial
This is an interventional treatment trial for Newly Diagnosed Multiple Myeloma
Eligibility Criteria
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
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D-VRD
Arm Description
treatment with D-VRD in NDMM
Outcomes
Primary Outcome Measures
rate of minimal residual disease negativity
rate of minimal residual disease negativity
Secondary Outcome Measures
Full Information
NCT ID
NCT05088330
First Posted
September 11, 2021
Last Updated
October 10, 2021
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05088330
Brief Title
A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
D-VRD
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D-VRD
Arm Type
Experimental
Arm Description
treatment with D-VRD in NDMM
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
DARA
Intervention Description
treatment with D-VRD in NDMM
Primary Outcome Measure Information:
Title
rate of minimal residual disease negativity
Description
rate of minimal residual disease negativity
Time Frame
end of 8 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
12. IPD Sharing Statement
Learn more about this trial
A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM
We'll reach out to this number within 24 hrs