Actively Recruiting
Phase III Clinical Study Comparing F182112 With Standard Treatments 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a drug called F182112 compared to standard treatments in patients with relapsed or refractory multiple myeloma (RRMM). This phase III clinical trial focuses on patients who have not responded to previous therapies containing proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. The main goal is to assess progression-free survival (PFS) as defined by established criteria from the International Myeloma Working Group (IMWG) in 2016. Participants will be randomly assigned to receive either F182112 alone or one of the standard treatment combinations: Pomalidomide with Bortezomib and Dexamethasone (PVd) or Selinexor with Bortezomib and Dexamethasone (SVd). Before randomization, investigators will select the appropriate standard care regimen based on the patient's disease status. The study is open-label, meaning both patients and researchers know which treatment is given. During the trial, participants will be closely monitored with regular clinical evaluations to measure disease progression and organ function. Researchers will assess blood and urine markers to track myeloma activity and safety. The primary outcome, progression-free survival, will be evaluated over a two-year period by an independent committee. The total study duration and follow-up will span several years, ensuring thorough safety and efficacy assessments throughout the trial.
CONDITIONS
Brief 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...
- Male or female patients aged 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma who failed therapy with proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies
- Provide informed consent and voluntarily agree to participate
- Have an ECOG performance status of 0 to 2
- Have at least one measurable disease parameter: serum M-protein 65 g/L, urine M-protein 6200 mg/24 h, or involved serum free light chain level 6100 mg/L with abnormal ratio
- Meet organ function requirements including blood counts, liver enzymes, and creatinine clearance 630 mL/min
- Prior treatment-related toxicities must be Grade 1 or less except certain exceptions
- Expected survival of at least 3 months
- Investigator pre-selects a standard of care treatment before randomization
You will not qualify if you...
- Central nervous system or meningeal involvement by multiple myeloma
- Other plasma cell disorders such as amyloidosis, leukemia, Waldenstr�f6m macroglobulinemia, or POEMS syndrome
- History of other malignancies within 3 years except certain low-risk or treated cancers
- Gastrointestinal dysfunction affecting drug absorption
- Cardiovascular risks including abnormal QTc, low ejection fraction, arrhythmias, recent heart events, severe heart failure, or uncontrolled hypertension
- Active infections requiring antimicrobial therapy or recent viral respiratory infections
- Positive viral serologies for hepatitis B or C, active autoimmune diseases including HIV, active syphilis, or active tuberculosis
- Recent live or attenuated vaccines within 4 weeks
- Major surgery within 4 weeks or planned during the study
- Recent or planned anti-myeloma therapies or investigational drugs within specified timeframes
- Previous allogeneic stem cell transplantation or BCMA-targeted therapy
- Pregnant or lactating women or those unwilling to use effective contraception
- Any severe or unstable medical, psychiatric, or other conditions affecting safety or study adherence
- Specific exclusions related to bortezomib, pomalidomide, selinexor intolerance or contraindications
- Use of strong CYP3A4 inducers prior to first dose
- Investigator deems patient unsuitable for participation
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 or until disease progression or discontinuation
Participants receive assigned drug treatment either with F182112 single-agent or standard of care regimens including Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd).
Regular visits scheduled according to treatment cycles
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjing, China
Actively Recruiting
Research Team
L
Lu gui Qiu Doctor
S
Shaohong Yin, Ext.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here