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
1 other identifier
interventional
360
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2024
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2024
CompletedFirst Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 27, 2025
June 1, 2025
2.8 years
July 5, 2024
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Adverse events （stage 1）
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Recommended stage 2 dose of SG301 (Stage 1)
Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data
Up to approximately 6 months.
Progression Free Survival (Stage 2)
Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).
From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
Secondary Outcomes (9)
Pharmacokinetics (PK): AUC
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK): Cmax
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Pharmacokinetics (PK):limination half-life (T1/2)
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Immunogenicity endpoints
From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
Overall Response Rate
From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.
- +4 more secondary outcomes
Study Arms (2)
SG301 Injection in combination with pomalidomide and dexamethasone
EXPERIMENTALParticipants 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 in combination with pomalidomide and dexamethasone
PLACEBO COMPARATORParticipants 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.
Interventions
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;
- Active hepatitis B, or C.
- Known HIV infection.
- Known active tuberculosis or positive treponema pallidum antibodies.
- Subjects with clinical significant organ dysfunction that does not meet the study needs.
- Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
- Known allergy to any component of the investigational medicinal product.
- Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100024, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006, China
Shanxi Provincial Hospital
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710000, China
Tianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310056, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Stage 1#Open-label Stage 2#Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 19, 2024
Study Start
June 14, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
June 27, 2025
Record last verified: 2025-06