To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
This study is expected to be carried out from November 2023 to November 2026. About 30 patients with high-risk/extramedullary multiple myeloma will receive mitoxantrone Hydrochloride Liposome combination regimen treatment. After evaluating of efficacy and safety of treatment, the principal investigator will write and publish the paper.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Initial diagnosis induction treatment regimen Lipo-MIT +VD (VMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Bortezomib: 1.3mg/m2 d1, 4, 8, 11, subcutaneous injection; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of VMD regimen induction therapy are performed. Reinduction therapy regimen after relapse Lipo-MIT + PD (PMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Pomalidomide: 4 mg/d d1-d21, orally; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of PMD regimen induction therapy are performed.
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGORR
objective remission rate
Time frame: 6 months
2-years PFS
2-years progression-free survival rate
Time frame: 2 years
2-years OS
2-years overall survival rate
Time frame: 2 years
2-years extramedullary relapse rate
2-years extramedullary relapse rate
Time frame: 2 years
DoR
duration of response
Time frame: 2 years
TTNT
time to the next treatment
Time frame: 2 year
MRD negative conversion rate
minimal residual disease negative conversion rate
Time frame: 6 months
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