Multiple Myeloma
Conditions
Interventions
therapy group:BRd+/-ASCT+IRd+IR
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years; 2. Estimated time of survival more than 3 months; 3. Subjects must have documented symptomatic multiple myeloma satisfying the International Myeloma Working Group (IMWG) 2014 criteria; 4. Subjects must have measurable disease with at least one of the following: serum M-protein >= 0.5g/dL; urine M-protein >= 200mg/24 hour; serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio; 5. Must not have been previously treated with any prior systemic therapy for multiple myeloma; 6. ECOG performance status 0-3 (ECOG = 3 is allowed only when due to myeloma disease); 7. Left ventricular ejection fraction >= 50% 8. Subjects must meet the following criteria at the screening stage: - Hemoglobin >= 6.0g/dl (transfusion of red blood cells or use of recombinant human erythropoietin is allowed). - The absolute number of neutrophils >= 0.75x109/L (granulocyte colony stimulating factor is allowed); - Platelet count is greater than or equal to 50 x109 / L (blood transfusion is allowed to reach the minimum platelet count); - Glomerular filtration rate GFR>50ml/min; - Aspartate aminotransferase (AST) <= 2.5x upper normal limit (ULN); - Alanine aminotransferase (ALT) <= 2.5 x ULN. 9. Volunteer to participate in this study, and sign an informed consent form before screening, willing to follow and have the ability to complete all trial procedures.
Exclusion criteria
Exclusion criteria: 1. The subjects received anti-myeloma treatment (excluding radiotherapy, bisphosphonates or short-term hormone therapy); 2. The subjects were pregnant or breastfeeding women; 3. The subjects had a history of malignancy (other than multiple myeloma). 4. The subjects had uncontrollable infections. 5. Neuropathic pain with peripheral neuropathy >= grade 3 or higher. 6. Subjects had any of the following: - Subjects had known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <50% of predicted normal). Note that FEV1 is only required for subjects suspected of COPD; - Subjects had known moderate or severe persistent asthma, or there is currently any type of uncontrolled asthma. (Please note that subjects currently suffering from controlled intermittent asthma or controlled mild persistent asthma may participate in this study). - The subjects had clinically significant heart diseases, including myocardial infarction, unstable angina pectoris, NYHA class III-IV or uncontrollable arrhythmias within 6 months before the start of the study. 7. Subjects were diagnosed as primary amyloidosis, MGUS or smoldering multiple myeloma 8. Participants had a diagnosis of Waldenstrom's disease, or other conditions in which IgM-M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions; 9. The subjects were known to be human immunodeficiency virus (HIV). 10. The subjects underwent major surgery within 2 weeks before treatment, but they did not fully recover from the operation; 11. Subjects had gastrointestinal diseases that might significantly alter oral drug absorption; 12. Patients known to be allergic to any study drug, its analogues or excipients of different formulations in any preparation. 13. Simultaneously treated with another study drug; 14. According to the researcher's judgment, the patients were not suitable to be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate;Minimal residual disease;Time to progression;Overall survival;Quality of life of patients;Adverse events; | — |
Countries
China
Contacts
Public ContactJunmin Chen
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed