Clinical trial
A Prospective, Open-label, Single-arm Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Daratumumab and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma
Name
JD-LK2023022-IR01
Description
A prospective, open-label, single-arm clinical study of mitoxantrone hydrochloride liposome injection combined with daratumumab and dexamethasone in the treatment of relapsed/refractory multiple myeloma
Trial arms
Trial start
2023-05-20
Estimated PCD
2025-01-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab
Dexamethasone 20 mg/d, on the same day of daratumumab injection; Mitoxantrone hydrochloride liposome injection: 20 mg/m2, d1; Daratumumab: 16 mg/Kg, once a week for the first 8 weeks; then changed to once every two weeks; Each cycle is 4 weeks long and the maximum number of cycles is 6.
Arms:
MDD group
Other names:
Mitoxantrone hydrochloride liposome
Size
20
Primary endpoint
ORR
6 months
Eligibility criteria
Inclusion Criteria:
* 1. Age :18-75 years, male or female; 2. Meet the definition of relapsed/refractory multiple myeloma; 3. At least one of the following can be evaluated:
1. Blood M protein level ≥10g/L;
2. 24-hour urine M protein level ≥200mg;
3. The difference between involved and uninvolved serum free light chain (dFLC) ≥100mg/L;
4. Extramedullary lesions with a diameterday≥2cm; 4. ECOG score 0-2 points; 5. Laboratory tests meet the following criteria:
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1. Absolute neutrophil count (ANC) ≥1.0x109/L;
2. Platelets (PLT) ≥50x109/L;
3. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN;
5. Creatinine clearance rate (Ccr) ≥30ml/min.
Exclusion Criteria:
* 1.Expected survival time \<3 months. 2.History of allergy to mitoxantrone or liposomal drugs; previous treatment with mitoxantrone or other anthracycline therapy, total cumulative dose of mitoxantrone \>360 mg/m2 (other anthracycline drugs are equivalent to 1mg mitoxantrone, 2mg doxorubicin or 0.5mg epirubicin).
3.Impaired cardiac function or significant heart disease, including but not limited to: a) Myocardial infarction or viral myocarditis within 6 months before screening. b) Existing heart disease requiring treatment at the time of screening, such as unstable angina pectoris, chronic congestive heart failure (NYHA≥2), arrhythmia, valve disease, etc., or persistent myocardial disease. c) QTc interval\>480ms at screening or long QTc syndrome. d) Ejection fraction less than 50% at screening or lower than the lower limit of the study center's examination value range.
4.HBsAg or HBcAb positive and HBV-DNA titer higher than the lower limit of the study center's detection value, or HCV antibody positive and HCV-RNA titer higher than the lower limit of the study center's detection value, or HIV antibody positive.
5.Bacterial infection, fungal infection or viral infection requiring systemic treatment within 1 week before administration of the study drug.
6.Pregnant or lactating women. 7.Other situations judged by investigator as inappropriate for participation in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a single-arm trial with ORR as the main endpoint. Due to limited data on mitoxantrone hydrochloride liposome injection, no statistical hypothesis will be made in this study to ensure the accuracy of the estimate.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-05-15
1 organization
1 product
1 indication
Organization
Second Affiliated Hospital of Soochow UniversityIndication
Multiple Myeloma