Relapsed or refractory multiple myeloma
Conditions
Interventions
Experimental group:Y150 intravenous infusion therapy
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Meet the definition of relapsed or refractory multiple myeloma, and have received at least two-line treatment failure in the past (including proteasome inhibitors and immunomodulators); or cannot tolerate the toxicity of PIs and IMiDs; or is resistant to one of the two drugs but cannot tolerate the toxicity of the other drug (Relapse MM: meets the 2016 IMWG efficacy criteria for clinical relapse or relapse after CR ; Refractory MM: The initial or salvage treatment did not achieve the effect of more than a small remission (at least 2 cycles after at least the effect of SD is still obtained), or the disease progresses during the treatment / within 60 days after the last treatment.); 3. There is measurable M protein (at least one of the three detection schemes): If it is IgG type multiple myeloma (MM), the serum monoclonal M protein needs to be >= 10 g/L, if it is IgA, IgD, IgE or IgM type MM, the serum monoclonal M protein needs to be >= 5 g/L; or urine M protein level >= 200 mg/24 hours; light chain multiple myeloma: serum free light chain >=10 mg/dL and the ratio of serum free light chain ?/? is abnormal; 4. The interval between the last anti-tumor treatment and the first administration of Y150 is >=4 weeks (including PIs, IMiDs), and the interval between the administration of CD38 monoclonal antibody is >=12 weeks; 5. ECOG physical status score is 0-2; 6. The investigator assesses that the subject's expected survival period is >=3 months; 7. Blood picture: Absolute neutrophil count (ANC) >=1.0x10^9/L (no stimulation factor used within 48h), hemoglobin >=70g/L (no red blood cell transfusion within 7 days), platelet >=50x10^ 9/L (no platelet transfusion within 7 days); 8. Liver: bilirubin = 30 mL/min; 10. Understand and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. The central nervous system is affected; 2. The daily dose of corticosteroid treatment exceeds the equivalent of 10 mg of prednisone within 1 week before the first study drug administration; 3. Patients with primary and secondary plasma cell leukemia; 4. Previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 12 weeks before receiving the study drug; 5. Received CAR-T treatment within 6 months before the first medication; 6. History of malignant tumors (non-multiple myeloma) within 5 years before the first study drug administration date (Except for skin squamous cell carcinoma and basal cell carcinoma, cervical or breast carcinoma in situ or other non-invasive lesions that the investigator and sponsor agree that they have been cured and have a very low risk of recurrence within 5 years); 7. Those who are known to be allergic to antibodies or human proteins; 8. Active infection (CTCAE >= grade 2); 9. Severe respiratory disease, the investigator judged that it is not suitable for selected patients; 10. A history of severe cardiovascular disease, including previous coronary artery bypass grafting or coronary stent implantation, myocardial infarction within 6 months, congestive heart failure (New York Heart Function Class III-IV) or unstable angina, uncontrolled hypertension, or left ventricular ejection fraction 480 ms; family or personal medical history of long or short QT syndrome; a history of obvious clinical ventricular arrhythmia, or are currently receiving anti-arrhythmic drug treatment or implanting a defibrillation device to treat ventricular arrhythmia; 12. Active autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, etc.), except for those whose disease was in a stable state at the time of enrollment (the symptoms were stable for more than 6 months without systemic immunosuppressive therapy); 13. Patients with severe hyperthyroidism or hypothyroidism; 14. Patients with uncontrollable diabetes and other metabolic diseases, severe gastrointestinal bleeding, severe diarrhea (CTCAE >= 2), patients with severe gastrointestinal obstruction requiring intervention; 15. Have a history of immunodeficiency, including a positive HIV test; 16. Human immunodeficiency virus (HIV) antibodies, Treponema pallidum (TP) antibodies, and hepatitis C virus (HCV) antibodies are positive; the detection of hepatitis B virus (HBV) surface antigen and hepatitis B virus DNA indicates active hepatitis B (HBV -DNA >= 1000cps/ml); 17. Those who have received (attenuated) live virus vaccine within 4 weeks before the first administration; 18. Women who are pregnant or breastfeeding, or both men and women who have a childbirth plan during the study period and within 6 months after the end of the medication; 19. Have a clear history of neurological or mental disorders, and the researcher believes that it affects the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; 20. The investigator believes that it is not suitable for patients participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Pharmacodynamics;Immunogenicity;Efficacy; | — |
Countries
China
Contacts
Public ContactQiu Lugui, Qi Junyuan, Cai Zhen
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed