A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma

Sponsor
Shandong New Time Pharmaceutical Co., LTD
Study ID
NCT07579234
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma

Key Dates

Start date
Jan 25, 2026
Status verified
Jan 2026
Primary completion
Jan 25, 2029
Completion
Jan 25, 2029

Study Design

Enrollment
261 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: F182112 single-agent
    F182112 single-agent
  • Active Comparator: PVd or SVd
    Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)

Primary Outcome Measure

the progression-free survival (PFS) evaluated by the Independent Review Committee (IRC) according to the 2016 IMWG criteria [ Time Frame: 2 year ]

Central Contacts

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