A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong New Time Pharmaceutical Co., LTD
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
F182112+P
DrugF182112 + P
F182112+CD38
DrugF182112+CD38
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: F182112 combined with different administration regimensExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Time frame
up to 2 yearsSecondary outcomes
1
Progression - Free Survival（PFS）
Time frame
Up to 2 years2
Minimal Residual Disease - negative rate
Time frame
Up to 2 years3
Number of Participants With Adverse Events and Serious Adverse Events
Time frame
Up to 2 years4
Overall Survival（OS）
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov