Actively Recruiting
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study Comparing SG301 Plus Pomalidomide and Dexamethasone Versus Placebo in Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Led by Hangzhou Sumgen Biotech Co., Ltd. · Updated on 2025-06-27
360
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding SG301 injection to the combination of pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma. This phase III, randomized, placebo-controlled, double-blind, multicenter study involves patients who have previously received treatments including lenalidomide and a proteasome inhibitor and have shown disease progression. The trial aims to confirm a recommended dose and compare treatment outcomes between the SG301 combination and placebo groups. Participants receive either SG301 injection or a placebo alongside pomalidomide and dexamethasone. SG301 and its placebo are given intravenously weekly for 8 weeks, then every two weeks afterward. Pomalidomide is taken orally daily on days 1 through 21 of each 28-day cycle, while dexamethasone is taken orally or intravenously on days 1, 8, 15, and 22 of each cycle, with dose adjustments for low body mass index. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During the study, participants undergo regular evaluations including safety monitoring for adverse events, pharmacokinetic assessments, and disease progression checks using established criteria. Outcome measures include progression-free survival, overall response rate, duration of response, overall survival, and minimal residual disease status. Assessments occur up to approximately four years, with follow-up visits every 4 to 8 weeks, depending on study stage and timing. Participants are closely monitored to ensure safety and treatment adherence throughout their involvement.
CONDITIONS
Brief Title
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form.
- Male or female aged 18 to 75 years.
- ECOG Performance Status score of 0, 1, or 2.
- Expected survival time of at least 3 months.
- Documented diagnosis of multiple myeloma with measurable disease.
- Received at least one prior anti-myeloma therapy including lenalidomide and a proteasome inhibitor.
- Documented evidence of disease progression on or after the last treatment.
- Adequate vital organ function.
- Women of childbearing potential must agree to contraception and have negative pregnancy tests before starting treatment.
You will not qualify if you...
- Primary refractory multiple myeloma with no minimal response to prior treatments.
- Bone independent extramedullary disease at screening.
- Primary refractory to prior CD38 monoclonal antibody therapy.
- Previous exposure to pomalidomide.
- Recent chemotherapy or small molecule therapy within 2 weeks or 5 half-lives before study treatment.
- Recent tumor biotherapy within 4 weeks or 5 half-lives before study treatment.
- Recent investigational agents within 4 weeks or 5 half-lives (minimum 14 days) before study treatment.
- Active hepatitis B or C infection.
- Known HIV infection.
- Active tuberculosis or positive syphilis antibodies.
- Significant organ dysfunction not meeting study requirements.
- Previous stem cell transplant before first study treatment dose.
- Allergy to any study drug components.
- Any medical or psychiatric condition that may interfere with study participation or safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until confirmed disease progression, unacceptable toxicity, or discontinuation
Participants receive SG301 injection or placebo in combination with pomalidomide and dexamethasone. Treatment cycles last 28 days, with SG301 or placebo given weekly for 8 weeks, then every 2 weeks thereafter. Participants continue treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Weekly visits for 8 weeks, then every 2 weeks thereafter
Trial Site Locations
Total: 12 locations
1
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100024
Actively Recruiting
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
7
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
8
Shanxi Provincial Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
9
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China, 710000
Actively Recruiting
10
Tianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
11
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
12
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China, 310056
Actively Recruiting
Research Team
J
Jing Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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