A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
SG301 Injection
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
SG301 placebo
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
pomalidomide
Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
dexamethasone
Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \< 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.