Relapsed/Refractory Multiple MyelomaPhase 1/2NCT05857982
Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab in people with Relapsed/Refractory Multiple Myeloma, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2023to 31 Dec 2025
- Phase
- Phase 1/2
- 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
- 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:
- Blood M protein level ≥10g/L;
- 24-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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Bingzong Li
About this study
Official title: 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
Read the 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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumabDrug
Also called Mitoxantrone hydrochloride liposome
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (5)
Adverse Eventsl
hematological and non-hematologica Adverse Eventsl (NCI CTCAE v5.0);
Measured: 6 months
DoR
Duration of response (DoR)
Measured: 1 year
1-year PFS rate
1-year progression-free survival rate (PFS)
Measured: 1 year
1-year PFS OS
1-year overall survival rate (OS)
Measured: 1 year
1-year extramedullary relapse rate.
1-year extramedullary relapse rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start20 May 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Bingzong LI, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857982
- Sponsor's protocol ID
- JD-LK2023022-IR01
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05857982
- Acronym / sponsor ID
- JD-LK2023022-IR01
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 May 2023 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MDD group | Experimental | Drug: Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumabDexamethasone 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
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Key exclusion criteria (5 listed)
- 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.
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/Dexamethasone/daratumumabAlso: Mitoxantrone hydrochloride liposomeDexamethasone 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 | MDD group |
Primary outcome
ORR
Time frame: 6 months
Objective response rate (ORR): Objective response includes partial response (PR), very good partial response (VGPR), complete response (CR), and strictly defined complete response (sCR).
5 secondary outcomes
Adverse Eventsl
Time frame: 6 months
DoR
Time frame: 1 year
1-year PFS rate
Time frame: 1 year
1-year PFS OS
Time frame: 1 year
1-year extramedullary relapse rate.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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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.
Bingzong LI principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab in people with Relapsed/Refractory Multiple Myeloma, run by Second Affiliated Hospital of Soochow University 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 11 inclusion and 5 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 15 May 2023. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bingzong LI (13776054037, lbzwz0907@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.