Trial · NCT06508983
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
NCT06508983, Phase 3, Recruiting, Hangzhou Sumgen Biotech Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients. Trials, record NCT06508983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06508983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
- NCT number
- NCT06508983
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 360 participants, estimated
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- SG301 Injection, SG301 placebo, pomalidomide, dexamethasone
- First posted
- 2024-07-19
- Last updated
- 2026-07-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06508983
GET https://conductscience.org/api/trials/v1/NCT06508983/registered