Multiple Myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1?Age: >=18 years old; 2?All patients meet the diagnostic criteria listed in the 2022 Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma to evaluate patients with measurable lesions ; 3?The main organs have no serious organic lesions (except for renal dysfunction caused by this disease), and meet the requirements of the following laboratory test indicators (conducted within 7 days before the first treatment): (1) a total bilirubin <= 1.5 times the upper limit of normal value (for the same age group); (2) Aspartate transaminase (AST) and alanine aminotransferase (ALT) are <= twice the upper limit of normal values for the same age group; (3) myocardial enzymes are less than twice the upper limit of normal values for the same age group;
Exclusion criteria
Exclusion criteria: 1?Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases; 2?According to the National Cancer Institute Common Criteria for Adverse Event Nomenclature (NCI CTCAE) version 4.0, baseline has grade 2 or higher peripheral neuropathy or neuropathic pain; 3?Patients with contraindications or life-threatening allergic reactions to drugs and excipients; 4?Epilepsy, dementia, and other mental disorders that require medication and cannot be understood; 5?Pregnant or lactating women; 6?COPD and asthma patients with FEV1<50% of the normal predicted value;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction incidence rate; | — |
Countries
China
Contacts
Shengjing Hospital of China Medical University