Multiple myeloma
Conditions
Interventions
Test group:Aponermin combined with Carfilzomib Pomalidomide, and Dexamethasone regimen
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have relapsed or be refractory in either of the following situations: (1) having undergone at least 3 lines of treatment (including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies), or (2) being exposed to 3 classes of drugs (including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies); the definition of relapsed disease is: initially achieving remission after previous treatment, and then experiencing disease progression confirmed according to IMWG criteria after stopping treatment for >60 days; the definition of refractory disease is: failing to achieve remission, or experiencing disease progression confirmed according to IMWG criteria during previous treatment or within =5 g/L; (2) urinary M protein >=200 mg/24h; and (3) in the case of an abnormal serum free light chain ratio, an affected free light chain level >=100 mg/L 4. ECOG score 3 months; 6. Laboratory test results should meet at least the indicators specified below: AST = 30 ml/min; 7. For female patients, (1) have been menopausal for at least 24 months prior to the screening visit or have been surgically sterilized; and (2) females of childbearing potential must: a) have negative results on two blood or urine HCG pregnancy tests (with a sensitivity of at least 25 mIU/mL) within 21 days prior to the initiation of study medication and within 72 hours of the start of study drug therapy; and b) agree to have a negative pregnancy test result on two blood or urine pregnancy tests (with a sensitivity of at least 25 mIU/mL) at least 28 days prior to the initiation of study drug therapy up to 28 days after the last period of absolute abstinence or two reliable methods of contraception from the study drug until 28 days after the last dose of study drug; c) Agree to be monitored for pregnancy during the course of the trial; 8. Female patients who are breastfeeding agree to stop breastfeeding during the course of treatment with this product and for 28 days after discontinuation of treatment with this product; 9. for male patients, even if surgically sterilized (e.g., vasectomy or ligation), they must agree to practice absolute abstinence or use an effective barrier method of contraception for the entire study treatment period up to 28 days after the last dose of study drug, and not be sperm donor; 10. The patient understands the purpose of the trial and the trial procedures, volunteers to participate in the trial, and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy or intolerance to the test drug or ingredients contained therein 2. Concurrent other neoplasms or previous history of neoplasms, or antineoplastic therapy (including major surgery) within the last 4 weeks, except for the following neoplastic diseases or those who have been living tumor-free for >= 3 years to date: basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, cervical carcinoma in situ, carcinoma in situ of the breast, incidental histological findings of prostate cancer (TNM clinical staging of T1a or T1b), or treated of prostate cancer; 3. The presence of current poorly controlled cardiac disease such as cardiac function class III or IV (NYAH classification) heart failure, uncontrolled atrial fibrillation, unstable angina pectoris, myocardial infarction within 12 months prior to enrollment; 4. With mental illness 5. With severe pulmonary infection or soft tissue skin infection or urinary tract infection; 6. The presence of a serious thrombotic event prior to treatment 7. A serious, uncontrolled medical disorder or active infection that may impair the subject's ability to receive treatment under the protocol, including, but not limited to, HIV-positive, syphilis-positive, active Hepatitis B virus, active Hepatitis C virus, uncontrollable diabetes mellitus, and patients undergoing hemodialysis or peritoneal dialysis 8. Unable or unwilling to receive prophylactic antithrombotic therapy 9. Conditions judged by the investigator to be unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Clinical benefit rate;Time to progression;safety;Duration of Response; | — |
Countries
China
Contacts
Public ContactCai Zhen
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed