Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508983
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 relapsedrefractory 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 relapsedrefractory multiple myeloma
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 relapsedrefractory 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 relapsedrefractory multiple myeloma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None