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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Bingzong LI
lbzwz0907@hotmail.com
13776054037
Time Frame
Start Date: 2023-05-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: MDD group
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital of Xuzhou Medical University
Leads: Second Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov