A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Sumgen Biotech Co., Ltd.

About this trial

The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Eligibility criteria

Qualifiers

Understand and voluntarily sign the informed consent form (ICF).

Males and females aged 18-75 years (inclusive)

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2

Expected survival time of ≥3 months.

Disqualifiers

Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.

Bone independent extramedullary disease at screening.

Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.

Previous exposure to pomalidomide.

Trial design

Treatments tested in this trial

  • SG301 Injection
  • SG301 placebo
  • pomalidomide
  • dexamethasone

Treatment groups

360 Participants
are divided into 2 treatment groups