Actively Recruiting
A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2025-12-31
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of F182112 combined with different administration regimens in patients who have relapsed or refractory multiple myeloma. This is a Phase II, single-arm, open-label study conducted at multiple centers, aiming to understand how well this treatment works and its safety profile in this patient group. The study plans to enroll about 90 patients and will test F182112 combined with varying administration schedules. The treatments include combinations such as F182112 plus P and F182112 plus CD38. Participants will receive these study drugs according to different regimens designed to assess their effects. During the study, researchers will monitor participants for up to two years, measuring outcomes like the objective response rate, progression-free survival, overall survival, duration of response, and minimal residual disease status. Safety will be tracked by recording adverse events and serious adverse events. Participants will undergo regular assessments and laboratory tests to evaluate treatment impact and safety throughout the study period.
CONDITIONS
Brief Title
A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma according to the IMWG 2016 criteria
- Previous treatment included lenalidomide used continuously for at least 2 cycles and a proteasome inhibitor
- ECOG performance status score of 0 to 2
- Meet at least one measurable disease indicator: serum M-protein 25 5 g/L, urine M-protein 25 200 mg/24 h, or involved serum free light chain level 25 100 mg/L with abnormal ratio (< 0.26 or > 1.65)
- Have not received pomalidomide previously and are not intolerant to pomalidomide
You will not qualify if you...
- Diagnosis of primary light-chain amyloidosis or plasma cell leukemia
- Symptoms of central nervous system involvement of multiple myeloma
- History of other malignancies within 3 years before the first dose, except multiple myeloma
- Active mucosal or visceral bleeding
- Previous treatment with BCMA-targeted therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive F182112 combined with different administration regimens to treat relapsed or refractory multiple myeloma.
Visits scheduled according to treatment regimen over up to 2 years
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
L
Lu gui Qiu Doctor
S
Shaohong Yin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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