Multiple Myeloma
Conditions
Interventions
Group 2:pomalidomide combined with cyclophosphamide, clarithromycin, dexamethasone
Group 1:pomalidomide combined with cyclophosphamide and dexamethasone
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent (IFC) has been signed. Informed consent was signed by the patient himself or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family will sign the informed consent; 2. Age: >= 18 years; 3. Patients with multiple myeloma who have received at least 1 line of treatment (induction, autologous transplantation and maintenance are regarded as the same line of treatment) (have not received pomalidomide before); 4. During or after receiving the 1-line regimen, subjects must have recorded disease progression (PD), and PD is judged by the investigator with reference to the IMWG criteria; 5. The hematological toxicity related to the previous treatment that occurs for the first time should be reduced to = 50%; 7. Liver function meets the following criteria: total bilirubin = 5g/L; (2) 24h urinary M protein excretion rate >= 0.2g (200mg); (3) Serum free light chain (sFLC) >= 100 mg/L and abnormal free light chain ratio; 11. Expected survival is more than 3 months; 12. Routine hematology combined with the following criteria (no platelet transfusion within 2 weeks before the screening examination): (1) Hemoglobin level >= 50g/L; (2) Absolute neutrophil count (ANC)>=1000mm^3/(1.0x10^9/L); (3) Platelet count >= 30,000/mm^3 (30x10^9/L); 13. Female subjects who may become pregnant must meet the following two conditions: (1) Agree to voluntarily sign the informed consent to take effective contraceptive measures during the use of the study drug and within 3 months after the last dose of the study drug; (2) The result of serum personal test was negative at the time of screening. NOTE: Women of childbearing potential are all women who have started menstruating and are not in the late stages of infertility and who have not undergone surgical sterilization (eg, hysterectomy, double tubal ligation, bilateral oophorectomy). Late period of amenorrhea refers to amenorrhea for more than 12 consecutive months due to unspecified reasons. Women who are using mechanical contraceptive methods such as oral contraceptives or IUDs should be considered fertile; 14. Male subjects (including those who have received vasectomy) must agree to use condoms in the sexual life of women of childbearing age, and since the date of signing the informed consent form, there is no plan to make women pregnant during the use of the study drug and within 3 months of the last receiving the study drug; 15. There are follow-up conditions. The patients were aware of the characteristics of the disease and voluntarily joined the study program for treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Asymptomatic (smoldering) multiple myeloma; 2. Patients with drug resistance or intolerance to all combination regimens according to the investigator's judgment. Note: Patients who progressed on maintenance therapy with lenalidomide 10 mg/d were not considered lenalidomide resistant; 3. Pregnancy or lactation; 4. Major surgery within 4 weeks before the first study drug; 5. Patients with unstable or active cardiovascular disease, who meet any of the following: (1) Symptomatic myocardial ischemia; (2) Uncontrolled and clinically meaningful conduction abnormalities (eg, excluding patients with ventricular arrhythmias controlled by antiarrhythmic drug therapy; Patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB) are not excluded); (3) Congestive heart failure (CHF) grade >= 3 as defined by the New York Heart Association (NYHA); (4) No acute myocardial infarction (AMI) occurred within 3 months before the first study medication; 6. Active infection that has not been controlled by drugs within 1 week before the first study drug; 7. Known HIV positive; 8. There is a serious thrombotic event before treatment; 9. Liver insufficiency (ALT and AST > 2 times the upper limit of normal); 10. Those with epilepsy, dementia and other mental disorders requiring drug treatment who cannot understand or comply with the research protocol; 11. According to the protocol or the judgment of the investigator, the patient has serious physical or mental illness that may interfere with participation in this clinical study; 12. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results; 13. Patients who are receiving other experimental drugs; 14. Other conditions deemed inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal residual disease in CR patients;12-month overall survival;12-month progression-free survival;Duration of relief;Safety;Targets related to IMiD resistance and CRBN upstream and downstream pathways; | — |
Countries
China
Contacts
Public ContactDu Juan
Shanghai Changzheng Hospital
Outcome results
None listed