A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma

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

This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.

• The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.

• Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.

• Have an ECOG performance status score of 0 - 2.

• Meet at least one of the following measurable disease indicators:

‣ Serum M - protein ≥ 5 g/L.

⁃ Urine M - protein ≥ 200 mg/24 h.

⁃ Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (\< 0.26 or \> 1.65).

Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Lu gui Qiu Doctor
Qiulg@ihcams.ac.cn
(+86)13821266636
Backup
Shaohong Yin
yinshaohong@vip.lunan.cn
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2028-05-20
Participants
Target number of participants: 90
Treatments
Experimental: F182112 combined with different administration regimens
F182112 combined with different administration regimens
Related Therapeutic Areas
Sponsors
Leads: Shandong New Time Pharmaceutical Co., LTD

This content was sourced from clinicaltrials.gov