Actively Recruiting
Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma
Led by Affiliated Hospital of Nantong University · Updated on 2024-02-07
30
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
CONDITIONS
Official Title
Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test) or extramedullary multiple myeloma
- Age between 18 and 70 years old, any gender
- Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 2
- Expected survival of 3 months or more
- Measurable lesions: extramedullary lesions 1.0 cm or larger; serum M protein 10 g/L or more and/or 24-hour urine M protein 200 mg or more
- Blood counts: neutrophil count at least 1.0 x 10^9/L (or at least 0.5 x 10^9/L if plasma cells in bone marrow exceed 50%), platelets at least 100 x 10^9/L (or at least 50 x 10^9/L if plasma cells in bone marrow exceed 50%), and hemoglobin above 8 g/dL
- Liver function: AST and ALT no more than 2.5 times upper normal limit (or 5 times if liver metastasis present), total bilirubin no more than 1.5 times upper normal limit, creatinine no more than 2.5 mg/dL
- Patients who received localized radiation therapy more than 4 weeks prior, with or without steroids, for pain or spinal cord/nerve root compression
- Signed informed consent form
You will not qualify if you...
- Impaired heart function or significant heart disease, including myocardial infarction or viral myocarditis within 6 months prior to screening
- Heart conditions requiring treatment at screening such as unstable angina, chronic congestive heart failure (NYHA grade 2 or higher), arrhythmia, valvular disease, or persistent cardiomyopathy
- QTc interval greater than 480ms or diagnosed long QTc syndrome during screening
- Cardiac ejection fraction below 50% or lower than the center's normal range during screening
- Active hepatitis B or C infection with specified viral load thresholds
- HIV infection
- Uncontrolled bacterial, fungal, or viral infections requiring systemic treatment within 1 week before study drug administration
- Pregnant or breastfeeding women
- Peripheral neuropathy or pain rated grade 2 or higher before treatment
- Received systemic chemotherapy within 28 days before first dose
- Resistance to or inability to accept pomalidomide treatment in relapsed patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
H
Hongming Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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