Trial · NCT06508983
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events （stage 1） | From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years. | AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination |
| Primary | Recommended stage 2 dose of SG301 (Stage 1) | Up to approximately 6 months. | Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data |
| Primary | Progression Free Survival (Stage 2) | 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. | Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone). |
| Secondary | 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. | The area under the curve (AUC) of serum concentration of the drug after the administration. |
| Secondary | 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. | Cmax to maximum drug concentration. |
| Secondary | 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. | Limination half-life (T1/2) of the drug after administration. |
| Secondary | 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. | Anti-SG301 antibody, neutralizing antibody (to be detected only in case of the presence of anti-SG301 antibody. |
| Secondary | 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. | 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 |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR 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. | ≥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. |
| Secondary | Duration of Response | 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. | Duration of response will be restricted to subjects who achieve a best objective response of PR or better. |
| Secondary | Overall Survival | From baseline through the end of study, assessed up to approximately 4 years. | Overall survival is defined as the time, in months, from randomization to the date of death from any cause. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) | 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. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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