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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-VRD | Experimental | treatment with D-VRD in NDMM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | treatment with D-VRD in NDMM |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of minimal residual disease negativity | rate of minimal residual disease negativity | end of 8 cycles |
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Inclusion Criteria
Age ≥ 18 years and ≤ 70 years, male or female;
Newly diagnosed multiple myeloma (NDMM) ï¼›
Transplant-eligibleï¼›
Non-17p-, t(4;14) , t(14;16)ï¼›
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):
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
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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D-VRD
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