multiple myeloma
Conditions
Interventions
Group 1:IAD regimens
Group 2:IRD regimens
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. previously untreated patients diagnosed with multiple myeloma based on IMWG criteria; 2. disease is measurable according to IMWG standard disease: there are measurable blood and urine M protein indicators (serum m-protein >=1g/dL (>=10 g/L), >=0.5 g/dL (>=5 g/L) in IgA, IgD, IgE or IgM multiple myeloma subjects; Or urine m-protein level >=200 mg/24 hours; Or light chain multiple myeloma, no measurable lesion in serum or urine, serum immunoglobulin free light chain (FLC) >=10 mg/dL and serum immunoglobulin kappa /lambda FLC ratio abnormal); Or a measurable extramedullary mass; 3. aged 65 or above; 4. IMWG geriatric scoring system (GA) (age score +ADL score +IADL score +Charlson coexisting disease index) >=2 points Vulnerable patients; Or MAYO aged vulnerability scoring system (nt-probnp >=300 ng/L, an ecog-ps >=2, and age >=70 years) was defined as vulnerable patients; 5. sign the informed consent; 6. during the whole study period, I can regularly go to the research institute for relevant testing, evaluation and management; 7. male and female patients with fertility potential must agree to use adequate contraception within 90 days from the date of signing the informed consent to the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. patients who are known to be allergic to any study drug, its analogues, or excipients of different formulations in any preparation; 2. patients with cardiovascular and cerebrovascular events such as acute myocardial infarction, acute heart failure, acute cerebral infarction or acute cerebral hemorrhage in the last half month; 3. patients who received live attenuated vaccine within 4 weeks before drug administration were first studied; 4. patients whose adherence to study protocols and follow-up times may be hindered by any serious medical or mental illness and other reasons (family, social and geographical).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| M protein quantification;bone marrow plasma cell percentage;overall survival;progression free survival;free light chain quantification;Bone marrow flow cytometry;bone marrow FISH;Bone marrow second-generation sequencing;MRI / CT;Immunostationary electrophoresis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver and kidney function;Routine blood; | — |
Countries
China
Contacts
Public ContactLi Bao
Beijing Jishuitan Hospital
Outcome results
None listed