Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM

NCT05052970 | Unknown Phase 1

• 1 other identifier: HE071-CSP-023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events (TEAEs)

  To indentify the incidence of TEAEs

  From the initiation of the first dose to 28 days after the last dose

Secondary Outcomes (6)

• Objective response rate (ORR)

  Throughout the study treatment(Up to 32 weeks)

• Clinical Benefit Rate(CBR)

  Throughout the study treatment(Up to 32 weeks)

• Disease control rate(DCR)

  Throughout the study treatment(Up to 32 weeks)

• Duration of response (DoR)

  Throughout the study completion.(An average of 12 months)

• Progression-free survival (PFS)

  Throughout the study completion.(An average of 12 months)

Study Arms (3)

12 mg/m ^ 2 dose group (ArmA)

EXPERIMENTAL

Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle). The dose of mitoxantrone hydrochloride liposome is 12 mg/m\^2

Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Bortezomib for Injection; Drug: Dexamethasone Acetate Tablets

16 mg/m ^ 2 dose group (ArmB)

EXPERIMENTAL

Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle). The dose of mitoxantrone hydrochloride liposome is 16 mg/m\^2

Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Bortezomib for Injection; Drug: Dexamethasone Acetate Tablets

20 mg/m ^ 2 dose group (ArmC)

EXPERIMENTAL

Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle). The dose of mitoxantrone hydrochloride liposome is 20 mg/m\^2

Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Bortezomib for Injection; Drug: Dexamethasone Acetate Tablets

Interventions

Mitoxantrone Hydrochloride Liposome injection DRUG

Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle

Also known as: Mitoxantrone Hydrochloride Liposome

12 mg/m ^ 2 dose group (ArmA); 16 mg/m ^ 2 dose group (ArmB); 20 mg/m ^ 2 dose group (ArmC)

Bortezomib for Injection DRUG

Bortezomib (1.3 mg/m\^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle

Also known as: Bortezomib

12 mg/m ^ 2 dose group (ArmA); 16 mg/m ^ 2 dose group (ArmB); 20 mg/m ^ 2 dose group (ArmC)

Dexamethasone Acetate Tablets DRUG

Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle

Also known as: Dexamethasone

12 mg/m ^ 2 dose group (ArmA); 16 mg/m ^ 2 dose group (ArmB); 20 mg/m ^ 2 dose group (ArmC)

Eligibility Criteria

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

You may qualify if:

• Patients fully understand and voluntarily participate in this study and sign informed consent;
• Aged 18-75 years, without gender limitation;
• Patients with relapsed or refractory multiple myeloma(confirmed by histologically or cytologically) who had received at least one prior line regular treatment;
• Patients have at least one of the following conditions:（1）Serum M protein≥10g/L;（2）Urine M protein≥200 mg/24h; （3）Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥100mg /L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• Laboratory tests meet the following conditions:
• Absolute neutrophil count (ANC) ≥1.5x10\^9/L (No G-CSF treatment within 1 week prior to the laboratory test);
• Platelet count ≥ 75x10\^9/L (No platelet transfusion within 1 week prior to the laboratory test);
• Total bilirubin ≤1.5upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN;
• Creatinine clearance(Ccr) ≥30mL/min.
• Females of childbearing potential must have a negative serum beta human chorionic gonadotrophin (β-hCG) pregnancy test result prior to enrollment and must agree to use an effective contraception method for the duration of the study treatment and 7 months after the last dose of study therapy.
• Males patients and their partners must agree to use an effective contraceptive method for the duration of the study treatment and 4 months after the last dose of study therapy.

You may not qualify if:

• Patients with amyloidosis or central nervous system invasion or on dialysis treatment.
• Life expectancy \< 3 months.
• History of allergy to mitoxantrone hydrochloride or liposomes；or previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) ≥350 mg/m\^2.
• History of allergy (except local injection reaction) or intolerance to bortezomib；or one of the following conditions occurred with prior bortezomib regimens: no treatment response (not reach MR)，disease progression within 6 months after the end of last dose.
• History of contraindications or intolerance to dexamethasone.
• Any anti-myeloma drug treatment or radiotherapy within 4 weeks prior to the first dose; or enrolled in any other clinical trials of anti-myeloma drug within 3 months prior to the first dose.
• History of autologous hematopoietic stem cell transplantation within 6 months prior to screening.
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
• Adverse events from the previous treatment have not resolved to ≤ Grade 1 (except for alopecia, hyperpigmentation).
• Patients with persistent Grade≥2 peripheral neuropathy or Grade 1 peripheral neuropathy with pain.
• Patients with impaired cardiac function or significant cardiac disease.
• HBsAg/HBcAb positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center,or human immunodeficiency virus (HIV) antibody positive.
• Patients with obvious digestive system dysfunction, which may affect intake, transport and absorption of the study drug.
• Active bacterial, fungal or viral infections that require systemic treatment within 1 week prior to the first dose
• Patients underwent major surgery within 6 weeks prior to the first dose, or had a surgical schedule during the study period;

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Zhou YL, Zhang JQ, Wang W, Bao L, Fang BJ, Gao D, Su LP, Chen WM, Yang GZ. Bortezomib, Mitoxantrone Hydrochloride Liposome, and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A Multi-Center, Open-Label Phase I Trial. Cancer Med. 2025 Apr;14(8):e70890. doi: 10.1002/cam4.70890.

  PMID: 40232151 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Bortezomib; Injections; dexamethasone acetate; Dexamethasone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wenming Chen

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na An

CONTACT

+86-010-63930582; anna@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: October 20, 2021
• Primary Completion: April 20, 2023
• Study Completion: June 20, 2024
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

CN (1)