Actively Recruiting
A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2026-05-12
261
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma
CONDITIONS
Official Title
A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide informed consent and be 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma who failed prior therapy with proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies
- Relapsed disease defined as progression after achieving minimal response or better
- Refractory disease defined as lack of response or progression within 60 days of last therapy
- ECOG performance status between 0 and 2
- At least one measurable disease marker: serum M-protein 5 g/L, urine M-protein 200 mg/24h, or involved serum free light chain 100 mg/L with abnormal ratio
- Adequate organ function including hematology, liver, and kidney criteria
- All prior treatment-related toxicities must be grade 1 or less, except specified exceptions
- Expected survival of at least 3 months
You will not qualify if you...
- Central nervous system involvement or meningeal symptoms from multiple myeloma
- Other plasma cell or related disorders like amyloidosis, plasma cell leukemia, Waldenstr�f6m macroglobulinemia, or POEMS syndrome
- History of other malignancies within 3 years except certain low-risk cancers
- Difficulty swallowing or active gastrointestinal issues affecting drug absorption
- Significant cardiovascular risks including abnormal ECG, low heart function, recent heart events, severe heart failure, or uncontrolled hypertension
- Active infections requiring treatment or recent viral respiratory infections
- Positive serology for active hepatitis B or C, autoimmune disease, HIV, syphilis, or active tuberculosis
- Recent live or attenuated vaccines within 4 weeks
- Major surgery within 4 weeks or planned during study
- Recent anti-myeloma therapies within specified timeframes before first dose
- Prior allogeneic stem cell or BCMA-targeted therapies
- Planned use of other anticancer or investigational drugs during study
- Severe or unstable medical or psychiatric conditions impacting safety or study compliance
- Pregnant or breastfeeding women or unwillingness to use contraception
- Inability to receive or intolerance to bortezomib, pomalidomide, or selinexor
- Use of strong CYP3A4 inducers prior to first dose
- Peripheral neuropathy grade 1 with pain or grade 2 or higher
- Investigator deems patient unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjing, China
Actively Recruiting
Research Team
L
Lu gui Qiu Doctor
CONTACT
S
Shaohong Yin, Ext.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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