Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Case series:iv infusion CX13-608
Sponsors
Renji Hospital Affiliated to Medical School, Shanghai Jiaotong University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years old male and female; 2. Patients who have been clinically diagnosed with multiple myeloma and who have received at least two standard treatment courses and have confirmed no response to treatment or have disease progression/recurrence; 3. Serum levels of myeloma lesions reached detectable levels, I.e., serum M protein = 10.0 g / L, or urine M protein = 200 mg/24h, or serum free light chain = 100 mg/L; 4. ECOG physical score 0-1 points; 5. Expected survival time is not less than 3 months; 6. No radiotherapy, chemotherapy, or immunotherapy was performed within 2 weeks before screening; 7. Organs function must meet the following requirements: (1) Bone marrow reservation: baseline white blood cell count> 2.0×10^9/L, absolute neutrophil count (ANC)> 1.0×10^9/L, platelets> 50×10^9/L, and hemoglobin> 8 g/dL; (2) Coagulation: prothrombin time (PT) and activated partial thromboplastin time (APPT) = 2 times the upper limit of normal (ULN); (3) Liver function: serum albumin = 3.0 g/dL; total bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2 × ULN, alkaline phosphatase = 250 IU/L; (4) Kidney: creatinine clearance = 50 mL/min (using the standard Cockcroft-Gault formula); (5) Heart: left ventricular ejection fraction (LVEF) = 45%; ECG is generally normal, QTcF male = 450 ms, female = 470 ms (after correction by Fridericia formula calculation); 8. Qualified patients (male and female) who have fertility must agree to use reliable methods of contraception (hormonal or barrier methods or abstinence) during the study period and at least 12 weeks after the last dose; women of childbearing age within 7 days prior to enrollment must have negative blood or urine pregnancy test; 9. Subjects must give informed consent to the study prior to the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Non-secretory multiple myeloma patients; 2. Plasma cell leukemia patients; 3. Any anti-myeloma drug therapy received within 14 days of the starting study drug treatment or any experimental non-drug treatment (eg, donor leukocyte/monocyte infusion) within 56 days of study drug initiation; Participate in any clinical trials of drugs or medical devices within 56 days; 4. Planned stem cell transplants within 28 days; 5.Subjects had grade 2 or higher peripheral neuropathy within 14 days prior to screening or when they first received drug treatment; 6. Those who have had significant active heart disease within the past 6 months, including the following: angina requiring surgery; poorly controlled hypertension after antihypertensive treatment (ie., systolic blood pressure> 160 mmHg, diastolic blood pressure> 90 mmHg) Myocardial infarction; II-IV congestive heart failure; acute myocardial infarction, unstable angina or variant angina occurred within 1 year; 7. Those who diagnosed as other malignant tumors patients within 3 years prior to enrollment, with the exception of the following tumors: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and squamous cell carcinoma of the skin that have been under the control; 8. Subjects are in acute infection and require medication; 9. Subjects who were positive for human immunodeficiency virus (HIV), Treponema pallidum, hepatitis B virus (HBV) or hepatitis C virus (HCV); 10. Subjects who had a clear history of mental disorders; 11. Subjects who had a history of drug abuse or history of drug use; 12. Inability to tolerate intravenous administration; 13. Pregnant or lactating women; 14. Women of childbearing age and men with fertility could not take effective and adequate dual contraceptives during the study drug treatment and 3 months after the study completion; 15. The investigator believed that there were other factors in the patient that might affect the study results, interfered with their participation in the entire study process, including previous or existing physical conditions, treatment or laboratory abnormalities, etc.; or the investigator believed that participating in the study did not maximize the patient's benefit; 16. The investigator determined that the patient was not suitable for this study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;tolerability;maximum tolerated dose;Dose limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters;Pharmacodynamic parameters;sCR;CR;VGPR;PR;MR;SD;PD; | — |
Countries
China
Contacts
Public ContactXiaoqing Fan
Ning Bo SanJian BIoPharmaceuticals, Inc
Outcome results
None listed