Multiple myeloma with renal insufficiency
Conditions
Interventions
Treatment group 1:DVd(Daratumumab + Bortezomib + dexamethasone) regimen
Treatment group 2:VPd(Bortezomib + Pomalidomide + dexamethasone) regimen
Sponsors
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: Individuals between 18 and 80 years of old. 2. Diagnosis of multiple myeloma as per the "Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (Revised Edition 2022)" (see Attachment 1). 3. Creatinine clearance at initial presentation must be =40mL/min. 4. Patients are expected to survive beyond three months from their diagnosis. 5. The absence of active infectious disease is mandatory. 6. Female patients with reproductive potential must have a negative pregnancy test during screening; adequate contraceptive measures must be adhered to by both male and female patients with reproductive potential throughout the treatment period and for a minimum of three months post-last dose. 7. Patients should have follow-up capabilities, understand the characteristics of their condition, and willingly consent to participate in this research protocol, including receiving treatment and follow-ups. 8. A signed informed consent form is required. This can either be signed by the patient themselves or a direct relative. If the patient's condition prevents them from signing due to medical reasons, then the informed consent form must be signed by the legal guardian or a direct relative.
Exclusion criteria
Exclusion criteria: 1. Individuals who underwent major surgery within the prior 30 days of being admitted to the study group; 2. Those presenting with a history of severe thromboembolic events during treatment preparation; 3. Elevated severity of cardiac disease: myocardial infarction (any event within the preceding six months), congestive heart failure (New York Heart Association [NYHA] category = III stage) and serious cardiac arrhythmia; 4. Patients afflicted with epilepsy, dementia or other mental disorders requiring medication but unable to comprehend or adhere to the research protocol; 5. According to the study plan or judgment by the researchers, patients harboring severe physical or psychological ailments that may impede their active participation in this clinical investigation; 6. Presence of substance abuse issues, medical, psychological or social circumstances likely to interfere with the participant's involvement in the study or evaluation of its outcomes; 7. Patients currently receiving experimental drug therapy; 8. Women who are lactating or pregnant; 9. Participants deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal response rate;Bone marrow MRD negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;complete response rate,CR;duration of response, DOR;Progression-free Survival, PFS;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactLijuan Chen
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Outcome results
None listed