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Trial Title:
Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT05857982
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Daratumumab
Mitoxantrone
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab
Description:
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.
Arm group label:
MDD group
Other name:
Mitoxantrone hydrochloride liposome
Summary:
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
Detailed description:
This study is a prospective, open-label, single-arm study. It is expected to include 20
patients with relapsed/refractory multiple myeloma who will receive combined treatment.
The recommended dose of mitoxantrone hydrochloride liposome injection is 20mg/m2 (the
dose can be adjusted according to the patient's tolerance, but the minimum dose is not
less than 12mg/m2). Each cycle is 4 weeks long and the maximum number of cycles is 6.
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; The study includes a screening
period (within 28 days), a treatment period (up to 6 cycles), and a follow-up period
(safety follow-up, survival follow-up, planned for 2 years).
The subjects signed an informed consent form and underwent baseline examination during
the screening period. Eligible patients were enrolled in the treatment period. All
subjects underwent relevant examinations as stipulated in the protocol during the
treatment process to observe efficacy and safety. After the treatment period ends, they
will enter the follow-up period.
Criteria for 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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Bingzong Li
Start date:
May 20, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857982
