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
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.
• Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
• Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
• Subjects must have documented evidence of PD on or after the last regimen.
• Adequate function of vital organs
• Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.
Locations
Other Locations
China
Beijing Chaoyang Hospital of Capital Medical University
RECRUITING
Beijing
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School Of Medicine
RECRUITING
Hangzhou
First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The First Affiliated Hospital Of Soochow University
RECRUITING
Suzhou
Shanxi Provincial Hospital
RECRUITING
Taiyuan
Tianjin Cancer University Airport Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
RECRUITING
Xi’an
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jing Yang
yangjing@sumgenbio.com
+86 010-56315401
Time Frame
Start Date:2024-06-14
Estimated Completion Date:2028-03-31
Participants
Target number of participants:360
Treatments
Experimental: SG301 Injection in combination with pomalidomide and dexamethasone
Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
Placebo_comparator: Placebo in combination with pomalidomide and dexamethasone
Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.