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A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

RecruitingPhase 2Ages 18 Years - anyAllShandong New Time Pharmaceutical Co., LTD
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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: 1. Serum M - protein โ‰ฅ 5 g/L. 2. Urine M - protein โ‰ฅ 200 mg/24 h. 3. Serum free light chain (FLC) test: Involved FLC level โ‰ฅ 100 mg/L and abnormal serum free light chain ratio (\< 0.26 or \> 1.65). Exclusion Criteria: * Patients with primary light - chain amyloidosis or plasma cell leukemia . * Patients with symptoms of central nervous system involvement of multiple myeloma. * Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose. * Patients with active mucosal or visceral bleeding. * Patients who have previously received BCMA - targeted therapy.
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What it tests

  • F182112+P
  • F182112+CD38
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Where

1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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