NCT07312188 A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT07312188 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong New Time Pharmaceutical Co., LTD |
| Condition | Relapsed or Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2028-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-07-02 with a primary completion date of 2028-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 ≥ 5 g/L. 2. Urine M - protein ≥ 200 mg/24 h. 3. Serum free light chain (FLC) test: Involved FLC level ≥ 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07312188 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07312188 currently recruiting?
Yes, NCT07312188 is actively recruiting participants. Contact the research team at Qiulg@ihcams.ac.cn for enrollment information.
Where is the NCT07312188 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07312188 clinical trial?
NCT07312188 is sponsored by Shandong New Time Pharmaceutical Co., LTD. The trial plans to enroll 90 participants.