Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

NCT05857982 | Unknown Phase 1 DMC

• 1 other identifier: JD-LK2023022-IR01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate (ORR): Objective response includes partial response (PR), very good partial response (VGPR), complete response (CR), and strictly defined complete response (sCR).

  6 months

Secondary Outcomes (5)

• Adverse Eventsl

  6 months

• DoR

  1 year

• 1-year PFS rate

  1 year

• 1-year PFS OS

  1 year

• 1-year extramedullary relapse rate.

  1 year

Study Arms (1)

MDD group

EXPERIMENTAL

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.

Drug: Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab

Interventions

Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab DRUG

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.

Also known as: Mitoxantrone hydrochloride liposome

MDD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Blood M protein level ≥10g/L;
• hour urine M protein level ≥200mg;
• The difference between involved and uninvolved serum free light chain (dFLC) ≥100mg/L;
• Extramedullary lesions with a diameterday≥2cm; 4. ECOG score 0-2 points; 5. Laboratory tests meet the following criteria:
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• Absolute neutrophil count (ANC) ≥1.0x109/L;
• Platelets (PLT) ≥50x109/L;
• Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN;
• Creatinine clearance rate (Ccr) ≥30ml/min.

You may not qualify if:

• 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).
• 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.
• 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.
• Bacterial infection, fungal infection or viral infection requiring systemic treatment within 1 week before administration of the study drug.
• Pregnant or lactating women. 7.Other situations judged by investigator as inappropriate for participation in this study.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bingzong LI

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingzong LI

CONTACT

13776054037; lbzwz0907@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: May 20, 2023
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CN (1)