Multiple Myeloma
Conditions
Interventions
DVd:The subjects received the Vd regimen (V: 1.3mg/m2 subcutaneous injection at d1,4,8,11, d: 20mg oral or intravenous injection at d1-4, 8-11) for the first course of treatment to reduce tumor burden
RVd:The subjects received the Vd regimen (V: 1.3mg/m2 subcutaneous injection at d1,4,8,11, d: 20mg oral or intravenous injection at d1-4, 8-11) for the first course of treatment to reduce tumor burden
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients met the diagnostic criteria of the International Myeloma Working Group (IMWG) and were diagnosed with active multiple myeloma.
Exclusion criteria
Exclusion criteria: 1 Patients with contraindications or life-threatening allergic reactions to drugs and excipients; 2 Having other incurable malignant tumors; 3 Diagnosed with plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrine disorders, M protein and skin lesions) or primary light chain amyloidosis during screening; 4 CNS involvement or multiple myeloma with meningeal involvement; 5 The subjects were pregnant, breastfeeding, or planning to become pregnant at the time of enrollment in this study or within 90 days after the last dose of study treatment; 6 There are the following heart diseases present: (1) New York Heart Association stage III or IV congestive heart failure; (2)Has experienced myocardial infarction or undergone coronary artery bypass surgery within = 6 months prior to diagnosis; (3)A clinically significant history of ventricular arrhythmia or unexplained syncope, non vasovagal or not due to dehydration; (4)Uncontrolled arrhythmia or clinically significant ECG abnormalities. 7 Any of the following situations occur: (1)Positive human immunodeficiency virus serum reaction; (2)Hepatitis B infection (i.e. HBsAg or HBV-DNA positive); (3)Active hepatitis C virus infection, i.e. positive HCV-RNA test result. Subjects with a positive history of HCV antibodies must undergo HCV-RNA testing. If a subject with a history of chronic hepatitis C infection (defined as positive for both HCV antibodies and HCV-RNA) completes antiviral treatment and no HCV-RNA is detected 12 weeks after completion of treatment, the subject is eligible to participate in the study; (4)COPD with FEV1<50% of the normal predicted value. It should be noted that subjects known or suspected to have COPD or asthma must undergo FEV1 testing. If FEV1 is less than 50% of the expected normal value, it must be excluded; (5)Suffering from moderate or severe persistent asthma (see Appendix 12) or uncontrolled asthma of any classification within the past 2 years. It should be noted that subjects with known or suspected asthma must undergo FEV1 testing. If FEV1 is less than 50% of the expected normal value, it must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negative rate;RRR;QOL; | — |
Countries
China
Contacts
Public ContactHuinan Jiang
Shengjing Hospital of China Medical University
Outcome results
None listed