multiple myeloma
Conditions
Interventions
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed active multiple myeloma according to IMWG 2016 criteria who have received at least one previous line of bortezomib-containing and/or lenalidomide-containing regimens, including at least one complete course of monotherapy, a regimen consisting of several drugs, or planned sequential therapy of multiple regimens; 2. Failed to respond to previous bortezomib-based and/or lenalidomide regimens or relapsed/progressed after response. Relapse was defined as recurrence of disease after a previous response according to objective laboratory and radiological criteria, including an increase of =25% in monoclonal protein (M-protein) in serum (absolute increase =0.5g/dL) or urine (absolute increase =200mg/ day). Or =25% difference between participating and nonparticipating serum free light chains (absolute increase >10mg/dL) or > 10% increase in absolute percentage of bone marrow plasma cells, or new (extramedullary) plasmacytoma or hypercalcemia. Including clinical recurrence, biochemical recurrence, recurrence after complete remission (CR), and recurrence of minimal residual disease (MRD). Relapsed/refractory multiple myeloma (RRMM) refers to non-response or progressive disease after treatment or within 60 days of the last treatment in patients who achieved minimal response or better to previous treatment. 3. Secretory multiple myeloma with measurable parameters (blood M component =5g/L; Urinary M component =200mg/24 hours; Involved blood FLC=100mg/L). 4. Age above 18 years old, regardless of gender; 5. ECOG 0-2, predicted survival time =12 weeks; 6. Subjects must have adequate organ function and meet all of the following laboratory tests before enrollment: A. Coagulation function: international normalized ratio (INR) <1.5 × ULN (INR <1.8 in the absence of a normal reference range) and activated partial thromboplastin time (APTT) 1.5 × ULN; b. Electrolyte: serum potassium =3.0 mmol/L; Serum magnesium =0.5 mmol/L; c. Liver function: ALT and AST =2.5× ULN; Serum bilirubin =1.5× ULN; d. Renal function: creatinine clearance (Ccr) =30 mL/min calculated according to Cockcroft-Gault formula. 7. The subject must be willing to provide valid evidence of diagnosis or bone marrow examination before treatment and to undergo bone marrow examination after treatment; 8. Non-lactating women; "For women of childbearing potential, the screening blood pregnancy test had to be negative for pregnancy, they had to have no plans for in vitro oocyte retrieval within 6 months after the last dose of study treatment, and they had to agree to use highly effective contraception." Unsterilized male subjects who had no plans to donate sperm and agreed to use highly effective contraception within 6 months after signing the informed consent form and the last dose of study treatment. 9. Subjects voluntarily participated in this study and provided written informed consent by themselves or by a guardian or impartial witness (if applicable). 10. The subjects or their guardians can communicate well with the investigators, and the subjects are willing to complete the study in accordance with the protocol
Exclusion criteria
Exclusion criteria: 1.Extramedullary plasma cell lesions; 2. Patients receiving other effective regimens; 3. The female patient is pregnant and lactating; 4. Allergic constitution, such as to two or more drugs or food allergy history; Or known to be allergic to its components; 5. Who received live vaccine (including live attenuated vaccine) within 4 weeks before enrollment and/or plan to receive live vaccine after enrollment; 6. Have participated in any interventional clinical trial and received a trial drug or medical device intervention within 4 weeks before enrollment (except for participants who participated in an overall survival follow-up study). 7. Malignant tumors other than MM within 5 years before enrollment, excluding: Tumors with a negligible risk of metastasis or death (e.g., expected 5-year OS>90%) and expected to be curable with treatment (e.g., cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer treated with radical surgery, ductal carcinoma in situ of the breast treated with radical surgery, etc.) Or any other tumor that has been cured (no evidence of disease recurrence within 5 years); 8. No one of the following circumstances: a. Nonsecretory MM; b. Active plasma cell leukemia, defined as peripheral plasma cells of up to 20% peripheral white blood cells or >2.0×109/L circulating plasma cells according to standard classification; C. aldenstrom macroglobulinemia; d. Primary amyloidosis; E. poems syndrome (multiple peripheral neuropathy, organomegaly, endocrine disorders, M-proteinemia, skin lesions); f. known human immunodeficiency virus (HIV) infection; g. Active hepatitis B (hepatitis B surface antigen [HBsAg] -positive) or hepatitis C infection based on blood testing at a central laboratory during the screening phase; h. Severe cardiovascular disease, including poorly controlled angina, arrhythmia, myocardial infarction within 6 months after the first medication, congestive heart failure with New York Heart Association (NYHA) functional class =3; i. Major surgery within 4 weeks before the first dose or planned during study participation; j. Acute infection requiring treatment (antibiotic, antifungal, or antiviral) within 14 days before the first dose; k. poorly controlled diabetes or hypertension within 14 days before the first dose; l. Peripheral neuropathy grade =3 within 2 weeks before the first dose 9. Inability to understand and comply with the study protocol or to sign informed consent; 8. During the study, women and men of childbearing age agreed to use appropriate and effective contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overal Survival;Safety;Tolerance; | — |
Countries
China
Contacts
Public ContactShukai Qiao
The Second Hospital of Hebei Medical University
Outcome results
None listed