multiple myeloma
Conditions
Interventions
Case series:bortezomib/lenalidomide/dexamethasone (VRD)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. Newly diagnosed symptomatic MM patients with measurable lesions according to the criteria of guidelines for the diagnosis and management of multiple myeloma in China(2017); 3. Eastern Cooperative Oncology Group (ECOG) performance status =2, expected survival >3 months ; 4. Measurable disease, defined by at least one of the following four measurements: (1) Serum M-protein >10.0 g/L detected by serum protein electrophoresis or immunoglobulin electrophoresis; (2) Urine light-chain (M-protein) = 1 g/24 hours; (3) Increased bone marrow plasma cells(bone marrow aspiration and/or biopsy) =30%; (4) Serum FLC >2-fold of upper normal limit in the absence of renal failure; 5. meet the requirement of the following laboratory test indicators (within 7 days before treatment): (1) TBIL= 1.5-fold of upper normal limit (of the same age); (2) Alanine transaminase (ALT) & aspartate transaminase (AST) =1.5-fold of upper normal limit (of the same age); (3) Myocardial enzyme <2-fold of upper normal limit(of the same age); (4) Absence of cardiac dysfunction; (5) Ratio of peripheral plasma cells < 50%or < 500/µL; 7. Subjects who have signed the ICF. The ICF must be signed by the patient per se, statutory guardian or direct relative.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days]); 2. Non-symptomatic MM including MGUS and smoldering myeloma; 3. Patients with amyloidosis; 4. Ongoing severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis); (1) Active hepatitis B infection. Hepatic serological testing is required for screening. If the hepatitis B surface antigen (HBsAg) is positive, the patient should be excluded. If the subject's hepatitis B core antibody is positive, it is necessary to confirm the negative result of DNA polymerase chain reaction (PCR) before randomization to be random; (2) Active hepatitis C infection. If the hepatitis C antibody is positive, it is necessary to confirm the negative result of RNA (PCR) before randomization to be random; (3) HIV positive; (4) Other active lung infections; 5. Prior history of malignancies, other than multiple myeloma; 6. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; 7. Severe thrombosis before treatment; 8. Patients with uncontrolled or severe cardiovascular disease including myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled angina, congestive heart failure clinically significant pericardial disease or cardiac amyloidosis (NT-Pro-BNP=1800pg/mL); 9. Subjects who underwent major surgery within 30 days prior to enrollment, or scheduled for surgery during the study period. Subjects scheduled to undergo surgery under local anesthesia may participate in the study; 10. Allergic to borate, mannose and thalidomide; 11. Subjects with epilepsy, dementia and other mental disorders requiring medication that cannot understood or followed the study protocol; 12. At the discretion of the protocol or the investigator, a patient with a severe physical or psychiatric disorder may interfere with the participation in this clinical study; Drug abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or assessment of the results of the study; 13. Patients undergoing other experimental drug treatment; 14. Pregnant or lactating females; 15. Researchers believe that not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Progression-free survival;Very Good Partial Response;Complete Response Rate;security index; | — |
Countries
China
Contacts
Public ContactJin Lu
Peking University People's Hospital
Outcome results
None listed