NCT06246162 Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma
| NCT ID | NCT06246162 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-11-13 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
Eligibility Criteria
Inclusion Criteria: * 1\. Diagnosed with high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test) or extramedullary multiple myeloma; 2. Age: 18-70 years old (including 18 and 70 years old), regardless of gender; 3. Eastern Cooperative Oncology Group physical performance score (ECOG): 0-2 points; 4. Expected survival ≥3 months; 5. Have "measurable lesions": extramedullary lesions ≧1.0cm or more; serum M protein ≥10g/L and/or 24-hour urine M protein ≥200mg; 6. Blood routine: neutrophil count ≥1.0×109/L; for patients with plasma cells in bone marrow \>50%, 0.5×109/L≤neutrophil count \<1.0×109/L is allowed. For patients with platelets ≥100×109/L; plasma cells in bone marrow \>50%, 50×109/L≤platelets \<100×109/L; hemoglobin \>8g/dL; 7. Liver function: AST and ALT ≤ 2.5 times the upper limit of normal value (for the same age group), or ≤ 5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin ≤ 1.5 times the upper limit of normal value; creatinine ≤ 2.5 mg/dL ; 8. Patients receiving localized radiation therapy, with or without concomitant steroids, for pain control or spinal cord/nerve root compression treatment are eligible. More than 4 weeks since the last radiotherapy treatment; 9. Sign the informed consent form. Exclusion Criteria: * 1\. Impaired heart function or suffering from significant heart disease, including but not limited to: 1. Myocardial infarction or viral myocarditis occurred within 6 months before screening; 2. There are heart diseases that require treatment at the time of screening, such as unstable angina, chronic congestive heart failure (NYHA ≥ grade 2), arrhythmia, valvular disease, etc. or persistent cardiomyopathy; 3. QTc interval \>480ms or suffering from long QTc syndrome during screening; 4. The cardiac ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center during screening. 2\. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL); 3. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 4. Suffer from uncontrollable bacterial infection, fungal infection or viral infection that requires systemic treatment within 1 week before the administration of the study drug; 5. Women who are pregnant or breastfeeding; 6. Peripheral neuropathy or pain of grade 2 (CTCAE5.0) or above before treatment; 7. Received systemic chemotherapy within 28 days before the first dose; 8. Relapsed patients are resistant to pomalidomide in previous treatment or cannot accept pomalidomide treatment
Contact & Investigator
Hongming Huang, PhD
STUDY DIRECTOR
Affiliated Hospital of Nantong University
Frequently Asked Questions
Who can join the NCT06246162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06246162 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06246162 currently recruiting?
Yes, NCT06246162 is actively recruiting participants. Contact the research team at hhmmmc@163.com for enrollment information.
Where is the NCT06246162 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT06246162 clinical trial?
NCT06246162 is sponsored by Affiliated Hospital of Nantong University. The principal investigator is Hongming Huang, PhD at Affiliated Hospital of Nantong University. The trial plans to enroll 30 participants.