- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052970
Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM
January 16, 2022 updated by: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This is a multicenter, open-label, phase I study aimed 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.
In the study, 60 patients will be recruited into three dose groups.
All patients will receive the treatment for the planned 8 cycles(28 days per cycle)until disease progression or unacceptable drug-related adverse events
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Na An
- Phone Number: +86-010-63930582
- Email: anna@mail.ecspc.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China
- Recruiting
- Beijing Chaoyang Hospital, Capital Medical University
-
Contact:
- Wenming Chen, Doctor
- Phone Number: 13910107759
- Email: 13910107759@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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Exclusion Criteria:
- 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;
- History of additional malignant tumor within 5 years, except for locally curable cancer that has been cured.
- Other medical conditions that, in the judgment of the investigator, may affect the patient's participation in this study.
- Pregnant or breastfeeding women;
Not suitable for this study as decided by the investigator due to other reasons.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 12 mg/m ^ 2 dose group (ArmA)
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
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Other Names:
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
Other Names:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Other Names:
|
Experimental: 16 mg/m ^ 2 dose group (ArmB)
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
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Other Names:
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
Other Names:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Other Names:
|
Experimental: 20 mg/m ^ 2 dose group (ArmC)
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
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Other Names:
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
Other Names:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-emergent adverse events (TEAEs)
Time Frame: From the initiation of the first dose to 28 days after the last dose
|
To indentify the incidence of TEAEs
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From the initiation of the first dose to 28 days after the last dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Throughout the study treatment(Up to 32 weeks)
|
ORR is defined as the proportion of patients who have a best overall response of partial response (PR),very good partial response(VGPR), complete response (CR) or stringent complete response (sCR) as per International Myeloma Working Group (IMWG)
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Throughout the study treatment(Up to 32 weeks)
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Clinical Benefit Rate(CBR)
Time Frame: Throughout the study treatment(Up to 32 weeks)
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CBR is defined as the proportion of patients who have a best overall response of minimal response(MR),PR,VGPR,CR or sCR as per IMWG
|
Throughout the study treatment(Up to 32 weeks)
|
Disease control rate(DCR)
Time Frame: Throughout the study treatment(Up to 32 weeks)
|
DCR is defined as the proportion of patients who have a best overall response of stable disease (SD),MR,PR,VGPR,CR or sCR as per IMWG
|
Throughout the study treatment(Up to 32 weeks)
|
Duration of response (DoR)
Time Frame: Throughout the study completion.(An average of 12 months)
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DoR is defined as the time from the first assessment of PR,VGPR,CR orsCR until the date of first occurrence of progressive disease (PD) as per IMWG
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Throughout the study completion.(An average of 12 months)
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Progression-free survival (PFS)
Time Frame: Throughout the study completion.(An average of 12 months)
|
PFS is defined as the time from the date of first dose until the date of first documented PD as per IMWG or death from any cause, whichever occurs first
|
Throughout the study completion.(An average of 12 months)
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Overall survival (OS)
Time Frame: Throughout the study completion.(An average of 36 months)
|
OS is defined as the time from the date of first dose until the date of death from any cause
|
Throughout the study completion.(An average of 36 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wenming Chen, Beijing Chaoyang Hospital affiliated to Capital Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2021
Primary Completion (Anticipated)
April 20, 2023
Study Completion (Anticipated)
June 20, 2024
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
September 13, 2021
First Posted (Actual)
September 22, 2021
Study Record Updates
Last Update Posted (Actual)
February 1, 2022
Last Update Submitted That Met QC Criteria
January 16, 2022
Last Verified
January 1, 2022
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
- Protease Inhibitors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Bortezomib
- Mitoxantrone
Other Study ID Numbers
- HE071-CSP-023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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