A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT07312188
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-07-02
2028-05-20
Brief Summary
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Detailed Description
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Primary objective:
The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Secondary objective:
The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate \[CRR\], progression - free survival \[PFS\], overall survival \[OS\], duration of response \[DOR\], time to response \[TTR\], time to progression \[TTP\], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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F182112 combined with different administration regimens
F182112 combined with different administration regimens
F182112+P
F182112 + P
F182112+CD38
F182112+CD38
Interventions
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F182112+P
F182112 + P
F182112+CD38
F182112+CD38
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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.
18 Years
ALL
No
Sponsors
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Shandong New Time Pharmaceutical Co., LTD
INDUSTRY
Responsible Party
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Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Countries
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Central Contacts
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Other Identifiers
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NTP-F182112-101
Identifier Type: -
Identifier Source: org_study_id