NCT07312188RecruitingPhase 2
A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 2 Jul 2025
- Primary completion date
- 20 May 2028
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Diseases
- Multiple myeloma
- NCT number
- NCT07312188
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 2 Jul 2025 to the primary completion date, 20 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received BCMA - targeted therapy.
Other illness
- 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.
Other
- Patients with primary light - chain amyloidosis or plasma cell leukemia .
- Patients with symptoms of central nervous system involvement of multiple myeloma.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.