Multiple Myeloma
Conditions
Interventions
VRD:Bortezomib Combined with Dexamethasone and Lenalidomide
VCD:Bortezomib combined with dexamethasone and cyclophosphamide
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The informed consent must be understood and signed voluntarily; 2. Aged over 18 years old at the time of signing the consent; 3. According to the IMWG diagnostic criteria in 2014, symptomatic multiple myeloma patients requiring immediate treatment were identified and had not previously received anti-myeloma treatment or had previously received any treatment but progressed with the disease; and the diseases identified by protein electrophoresis were as follows: serum monoclonal abnormal proteins (M protein) levels of IgG 1.0 g/dl, IgA 0.5 g/dl, light chain serum M protein 1.0 g/dl and urine M protein 200 mg/24 H; 4. Fertile women or men should adopt effective contraceptive methods according to local regulations on contraceptive methods used by subjects in clinical trials during and after the study. These restrictions apply one year after the end of treatment; 5. Serum or urine pregnancy tests performed by fertile women during screening were negative. Pregnant or lactating women could not participate in this study; 6. A written informed consent must be signed (or signed by a legal representative) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients were treated with anti-myeloma therapy before (excluding radiotherapy, bisphosphonates, or single short-term steroids (i.e. less than or equal to 20 mg/d of dexamethasone for 4 days); 2. Any serious illness that can lead to an unacceptable risk in patients participating in this study. These include, but are not limited to, myocardial infarction, heart failure grade III-IV, uncontrollable atrial fibrillation or hypertension in the past six months, diseases requiring chronic steroid or immunosuppressive therapy, such as rheumatoid arthritis, multiple sclerosis and lupus, and those other than research therapy. Additional steroids or immunosuppressive therapy may be required; 3. Pregnant or lactating women; 4. Malignant tumors other than multiple myeloma have a history unless the patient has not survived for more than three years. Exceptions include basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of cervix, carcinoma in situ of breast, and prostate cancer (TNM stage T1A or T1b); 5. There was a history of stroke or intracranial hemorrhage in the first 6 months; 6. Live vaccines and attenuated live vaccines were inoculated within the first four weeks at random; 7. Allergic reactions are known to all components of the schemes used, including drug solvents and excipients. 8. Researchers believe that life-threatening diseases, symptoms or organ dysfunction may endanger the safety of subjects or risk the results of research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Complete response rate;Genome expression in MM cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-free survival;Overall survival;Patients' quality of life; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed