multiple myeloma
Conditions
Interventions
Group of multiple myeloma (denosumab ih):None
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Be able to understand and be willing to sign informed consent. 2) Patients aged >= 18 years with multiple myeloma diagnosed according to IMWG 2014 criteria 3) Patients with MM who achieve = VGPR remission after receiving first-line anti-myeloma therapy 4) Establish the time interval from diagnosis to enrollment<= 18 months 5) ALT, AST, and total bilirubin do not exceed 2 times the upper limit of normal 6) Correct blood calcium between 2.0-2.9mmol/L 7) During the entire research period, we can regularly visit the research institution for relevant testing, evaluation and management. 8) Male and female patients of childbearing potential must agree to use adequate contraception from the date of signing the informed consent form until 90 days after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1) Patients with known hypersensitivity to excipients (including vitamin D and calcium) in any investigational drug or different formulations in any formulation. 2) In the past half month, cardiovascular and cerebrovascular events such as acute myocardial infarction, acute heart failure, acute cerebral infarction or acute cerebral hemorrhage have occurred. 3) Parathyroid disease 4) Patients who received live attenuated vaccine within 4 weeks prior to first study drug administration. 5) Life expectancy is less than 3 months 6) Oral and maxillofacial surgery is required, including tooth extraction 7) Oral and maxillofacial wounds that do not heal, including tooth extractions 8) Plan invasive dental procedures 9) Active infection requires intravenous anti-infective therapy 10) Pregnant or lactating women, or planning to become pregnant within 5 months after the end of treatment 11) Inability to complete follow-up or due to any serious medical or psychiatric illness and other reasons (family, social and geographical conditions) that may prevent it Patients who comply with the study protocol and follow-up time 12) Circumstances that the investigator considers inappropriate for enrollment or affect the analysis of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone density;circulating plama cells;Markers of bone metabolism;musle mass;Myeloid-derived suppressor cells; | — |
Countries
China
Contacts
Public ContactLi Bao
Beijing Jishuitan Hospital
Outcome results
None listed