A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: F182112+P, F182112+CD38.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma
Overview
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.
Detailed description
The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.
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.
Interventions
- Drug F182112+P
F182112 + P - Drug F182112+CD38
F182112+CD38
Primary outcome measures
- Objective response rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (5)
- Progression - Free Survival（PFS） [Time frame: Up to 2 years]
- Minimal Residual Disease - negative rate [Time frame: Up to 2 years]
- Number of Participants With Adverse Events and Serious Adverse Events [Time frame: Up to 2 years]
- Overall Survival（OS） [Time frame: Up to 2 years]
- Duration of Response（DOR） [Time frame: up to 2 years]
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:
- 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).
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology & Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07312188 · NTP-F182112-101