Multiple Myeloma
Conditions
Interventions
Research group:Aponermin for injection
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with RRMM who have received 1-3 lines of therapy; 2.Age 18-75 years old, male or female; 3.Have measurable M protein, that is, have at least one of the following 3 measurements: (1) serum M protein >=5g/L; (2) Urinary M protein >=200mg/24h; (3) In the case of abnormal serum free light chain ratio, the level of involved free light chain >=100mg/L; 4.ECOG score =1.0×10^9/L; Platelet count (PLT) >=50×10^9/L; Hemoglobin > 70g/L; Aspartate aminotransferase (AST) =30ml/min; Corrected serum calcium =3.5mmol/L. 7.For female patients, (1) had been menopausal for at least 24 months before the screening visit, or had undergone surgical birth control; (2) Women who are fertile must: a) have two negative blood or urine HCG pregnancy tests (sensitivity of at least 25 mIU/mL) within 21 days before starting the study drug and within 72 hours; b) agree to practice absolute abstinence or two reliable methods of contraception for a period of at least 28 days before starting the study drug until 28 days after the last study drug treatment; c) Consent to pregnancy monitoring during the trial; 8.Lactating female patients agree to stop breastfeeding during the use of this product and within 28 days after discontinuation of treatment with this product; 9.For male patients, even those who have been surgically sterilized (such as vasectomies or ligation), they must agree to practice absolute abstinence or effective barrier contraception for the entire study treatment period up to 28 days after the last study drug treatment, and no sperm donation; 10.Patients understand the purpose and procedure of this trial, voluntarily participate in this trial, and sign a written informed consent;
Exclusion criteria
Exclusion criteria: 1.Allergic or intolerant to the investigational drug product or its ingredients; 2.Received any conventional or experimental drug treatment within 4 weeks; 3.Patients who also have other tumors or have a history of tumors, or have received anti-tumor therapy (including major surgery) in the last 4 weeks, except those with the following tumor diseases or who have lived tumor free for more than 3 years to date: Basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, cancer of the prostate, incidental histological findings (TNM clinical stage T1a or T1b), or prostate cancer that has been treated; 4.Present poorly controlled heart disease, such as grade III or IV (NYAH) heart failure, uncontrolled atrial fibrillation, unstable angina pectoris, and myocardial infarction in the 12 months prior to enrollment; 5.Suffer from mental illness; 6.With severe lung infection or skin soft tissue infection or urinary tract infection; 7.There were serious thrombotic events before treatment; 8.A serious, uncontrolled medical disorder or active infection that may impair a subject's ability to receive treatment under protocol, including but not limited to HIV-positive, syphile-positive, hepatitis B virus active, hepatitis C virus active, uncontrolled diabetes, and patients undergoing hemodialysis or peritoneal dialysis; 9.Inability or unwillingness to receive preventive antithrombotic therapy; 10.Cases judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) after 4 courses of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS);Adverse event; | — |
Countries
China
Contacts
Public ContactBaijun Fang
He'nan Cancer Hospital
Outcome results
None listed