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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
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.
Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGGuangzhou First People's Hospital
Guangzhou, Guangdong, China
Adverse events (stage 1)
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
Time frame: 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
Time frame: 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).
Time frame: 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.
Pharmacokinetics (PK): AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame: 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
Cmax to maximum drug concentration.
Time frame: 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)
Limination half-life (T1/2) of the drug after administration.
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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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGFirst Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
RECRUITINGShanxi Provincial Hospital
Taiyuan, Shanxi, China
RECRUITINGThe Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China
RECRUITINGTianjin Cancer University Airport Hospital
Tianjin, Tianjin Municipality, China
RECRUITING...and 2 more locations
Time frame: 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
Anti-SG301 antibody, neutralizing antibody (to be detected only in case of the presence of anti-SG301 antibody.
Time frame: 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
ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response
Time frame: 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.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate)
≥VGPR Rate (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), and very good partial response (VGPR) as best overall response.
Time frame: 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.
Duration of Response
Duration of response will be restricted to subjects who achieve a best objective response of PR or better.
Time frame: From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.
Overall Survival
Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
Time frame: From baseline through the end of study, assessed up to approximately 4 years.
Percentage of Participants With Minimal Residual Disease (MRD)
MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR or sCR, to determine the depth of response at the molecular level.
Time frame: From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.