Multiple Myeloma with Secondary Extramedullary Disease
Conditions
Interventions
Treatment Group:Fludarabine 20 mg/m2/day, intravenous infusion, days 1–3
Liposomal mitoxantrone 3 mg/m2/day, intravenous infusion, day 1
Dexamethasone 20–40 mg, intravenous infusion, days 1–4
Venetoclax tablets 100 mg, oral administration, days 1–7
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Relapsed/refractory multiple myeloma that has received 1~3 lines of therapy, with pathological and/or clinical diagnosis of extramedullary invasion; 2. Age over 18 years old, gender is not limited; 3. Eastern Oncology Cooperative Group Physical Performance Score (ECOG): 0-3 points; 4. Have "measurable lesions": extramedullary lesions>=1.0cm or more; 5. Liver function: AST and ALT=30ml/min; 7. Be able to accept adverse reactions and efficacy observation according to the requirements of the test; 8. Patients understand the purpose and steps of this trial, voluntarily participate in this trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Impaired cardiac function or significant cardiac disease, including but not limited to: 1) Myocardial infarction, viral myocarditis within 6 months prior to screening; 2) Presence of heart disease requiring treatment at screening, such as unstable angina, chronic congestive heart failure (NYHA>=grade 2), arrhythmia, valvular disease, etc., or persistent cardiomyopathy; 3) QTc interval >480ms at screening or with long QTc syndrome; 4) Cardiac ejection fraction less than 50% or lower than the lower limit of the range of the study center's examination value at screening. 2. Active hepatitis B and hepatitis C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeds 1x10^3 copies/mL; hepatitis C virus RNA exceeds 1x10^3 copies/mL); 3. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 4. Uncontrollable bacterial, fungal, or viral infections requiring systemic treatment within 1 week prior to study drug administration; 5. There are situations where other researchers judge that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Duration of remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactDijiong Wu
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Outcome results
None listed