Relapsed or Refractory Multiple MyelomaPhase 1NCT05052970
Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome injection, Bortezomib for Injection and Dexamethasone Acetate Tablets in people with Relapsed or Refractory Multiple Myeloma, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome injection, Bortezomib for Injection and Dexamethasone Acetate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 20 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- -
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality
Wenming Chen, Doctor, 13910107759, 13910107759@163.com
About this study
Official title: 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.
Read the 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
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Mitoxantrone Hydrochloride Liposome injection, Bortezomib for Injection, Dexamethasone Acetate Tablets
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome injectionDrug
Also called Mitoxantrone Hydrochloride Liposome
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Bortezomib for InjectionDrug
Also called Bortezomib
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
Dexamethasone Acetate TabletsDrug
Also called Dexamethasone
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Bortezomib for Injection; Drug: Dexamethasone Acetate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
To indentify the incidence of TEAEs
Measured: From the initiation of the first dose to 28 days after the last dose
Secondary outcomes (6)
Objective response rate (ORR)
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)
Measured: Throughout the study treatment(Up to 32 weeks)
Clinical Benefit Rate(CBR)
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
Measured: Throughout the study treatment(Up to 32 weeks)
Disease control rate(DCR)
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
Measured: Throughout the study treatment(Up to 32 weeks)
Duration of response (DoR)
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
Measured: Throughout the study completion.(An average of 12 months)
Progression-free survival (PFS)
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
Measured: Throughout the study completion.(An average of 12 months)
Overall survival (OS)
OS is defined as the time from the date of first dose until the date of death from any cause
Measured: Throughout the study completion.(An average of 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start20 Oct 2021
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenming Chen, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052970
- Sponsor's protocol ID
- HE071-CSP-023
- Status last verified
- Jan 2022
- First submitted
- 13 Sep 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40232151
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05052970
- Acronym / sponsor ID
- HE071-CSP-023
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12 mg/m ^ 2 dose group (ArmA) | Experimental | Drug: Mitoxantrone Hydrochloride Liposome injection, Drug: Bortezomib for Injection, Drug: Dexamethasone Acetate TabletsPatients 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 |
| 16 mg/m ^ 2 dose group (ArmB) | Experimental | Drug: Mitoxantrone Hydrochloride Liposome injection, Drug: Bortezomib for Injection, Drug: Dexamethasone Acetate TabletsPatients 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 |
| 20 mg/m ^ 2 dose group (ArmC) | Experimental | Drug: Mitoxantrone Hydrochloride Liposome injection, Drug: Bortezomib for Injection, Drug: Dexamethasone Acetate TabletsPatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome injectionAlso: Mitoxantrone Hydrochloride LiposomeMitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle | Drug | 12 mg/m ^ 2 dose group (ArmA), 16 mg/m ^ 2 dose group (ArmB), 20 mg/m ^ 2 dose group (ArmC) |
| Bortezomib for InjectionAlso: BortezomibBortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle | Drug | 12 mg/m ^ 2 dose group (ArmA), 16 mg/m ^ 2 dose group (ArmB), 20 mg/m ^ 2 dose group (ArmC) |
| Dexamethasone Acetate TabletsAlso: DexamethasoneDexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle | Drug | 12 mg/m ^ 2 dose group (ArmA), 16 mg/m ^ 2 dose group (ArmB), 20 mg/m ^ 2 dose group (ArmC) |
Primary outcome
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
6 secondary outcomes
Objective response rate (ORR)
Time frame: Throughout the study treatment(Up to 32 weeks)
Clinical Benefit Rate(CBR)
Time frame: Throughout the study treatment(Up to 32 weeks)
Disease control rate(DCR)
Time frame: Throughout the study treatment(Up to 32 weeks)
Duration of response (DoR)
Time frame: Throughout the study completion.(An average of 12 months)
Progression-free survival (PFS)
Time frame: Throughout the study completion.(An average of 12 months)
Overall survival (OS)
Time frame: Throughout the study completion.(An average of 36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 40232151Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenming Chen principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome injection, Bortezomib for Injection and Dexamethasone Acetate Tablets in people with Relapsed or Refractory Multiple Myeloma, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na An (+86-010-63930582, anna@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: From the initiation of the first dose to 28 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.