Treatment for high-risk multiple myeloma using a new drug combination
Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma:A Single-arm, Single-center, Prospective Clinical Trial
This study is testing a new drug combination to see if it can help people with high-risk multiple myeloma feel better and stay safe during treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06246162 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination regimen involving mitoxantrone hydrochloride liposome for patients diagnosed with high-risk or extramedullary multiple myeloma. The study will enroll approximately 30 participants aged 18 to 70 years, who will receive the treatment over a period from November 2023 to November 2026. The primary goal is to assess how well this new regimen works and its safety profile, with results expected to be published by the principal investigator.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with high-risk multiple myeloma or extramedullary lesions.
Not a fit: Patients with low-risk multiple myeloma or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk multiple myeloma, potentially improving their outcomes.
How similar studies have performed: While there have been studies on multiple myeloma treatments, this specific combination regimen is novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantong, Jiangsu
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Hongming Huang, PhD
- Email: hhmmmc@163.com
- Phone: +8615006281688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.