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

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

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

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bingzong LI; Phone Number: 13776054037; Email: lbzwz0907@hotmail.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • Second Affiliated Hospital of Soochow University
      • Contact: Bingzong Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MDD group; 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; 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.; Other Names: Mitoxantrone hydrochloride liposome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Eventsl	hematological and non-hematologica Adverse Eventsl (NCI CTCAE v5.0);	6 months
DoR	Duration of response (DoR)	1 year
1-year PFS rate	1-year progression-free survival rate (PFS)	1 year
1-year PFS OS	1-year overall survival rate (OS)	1 year
1-year extramedullary relapse rate.	1-year extramedullary relapse rate.	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University
• Collaborators: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Principal Investigator: Bingzong Li, Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2023
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dexamethasone; Daratumumab; Mitoxantrone
• Other Study ID Numbers: JD-LK2023022-IR01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No