Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma

NCT06246162 | Recruiting Phase 1

• 1 other identifier: 2023-TDFY-052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• ORR

  objective remission rate

  6 months

Secondary Outcomes (6)

• 2-years PFS

  2 years

• 2-years OS

  2 years

• 2-years extramedullary relapse rate

  2 years

• DoR

  2 years

• TTNT

  2 year

Study Arms (1)

Lipo-MIT combination regimen group

EXPERIMENTAL

Initial diagnosis induction treatment regimen Lipo-MIT +VD (VMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Bortezomib: 1.3mg/m2 d1, 4, 8, 11, subcutaneous injection; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of VMD regimen induction therapy are performed. Reinduction therapy regimen after relapse Lipo-MIT + PD (PMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Pomalidomide: 4 mg/d d1-d21, orally; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of PMD regimen induction therapy are performed.

Drug: Lipo-MIT combination regimen

Interventions

Lipo-MIT combination regimen DRUG

Initial diagnosis induction treatment regimen Lipo-MIT +VD (VMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Bortezomib: 1.3mg/m2 d1, 4, 8, 11, subcutaneous injection; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of VMD regimen induction therapy are performed. Reinduction therapy regimen after relapse Lipo-MIT + PD (PMD): Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Pomalidomide: 4 mg/d d1-d21, orally; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of PMD regimen induction therapy are performed.

Lipo-MIT combination regimen group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Impaired heart function or suffering from significant heart disease, including but not limited to:
• Myocardial infarction or viral myocarditis occurred within 6 months before screening;
• 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;
• QTc interval \>480ms or suffering from long QTc syndrome during screening;
• 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.
• \. 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hongming Huang, PhD

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Central Study Contacts

Hongming Huang, PhD

CONTACT

+8615006281688; hhmmmc@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: February 7, 2024
• Study Start: November 13, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)