NCT06508983

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	SG301 Injection	Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
DRUG	SG301 placebo	Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
DRUG	pomalidomide	Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
DRUG	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.

Timeline

• Start date: 2024-06-14
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2024-07-19
• Last updated: 2025-06-27

Locations

12 sites across 1 country: China