Clinical trial · Interventional
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
NCT05088330CI-TRIAL-00054584unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- D-VRD
- description
- treatment with D-VRD in NDMM
- interventionNames
- Drug: Daratumumab
Primary outcomes (1)
- measure
- rate of minimal residual disease negativity
- timeFrame
- end of 8 cycles
- description
- rate of minimal residual disease negativity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
\-References
Publications (0)
Data not yet available
No reference posted for this study.