Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06087653
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-09-20
Brief Title:
Safety Efficacy and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma MM
Sponsor:
Starton Therapeutics Inc
Organization:
Starton Therapeutics Inc
Study Overview
Official Title:
A Protocol to Assess the Safety Efficacy and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide STAR-LLD for the Treatment of Multiple Myeloma MM
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous SC infusion STAR-LLD in combination with dexamethasone and a proteasome inhibitor PI
Secondary Objectives
To assess the immunologic activity of natural killer NK cells and T cells for innate and humoral immunity
To establish the pharmacokinetic PK profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations
To determine pharmacodynamic PD changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide
Evaluate changes in efficacy indicators including objective response rate ORR progression-free survival PFS and duration of response DOR
Exploratory Objective
To assess the impact of STAR-LLD on patient reported symptoms and outcomes Primary Endpoints
The grade frequency and relationship of treatment-emergent adverse events TEAEs including adverse events of special interest AESIs gastrointestinal GI toxicity fatigue hematologic toxicity rash non-infusion site
The observation of dose-limiting toxicities DLTs of STAR-LLD during Cycle 1 Secondary Endpoints
Immune profiles functional assays for NK cell activation and antigen specific T-cell activity
Blood concentrations of lenalidomide at on Day 1 and at steady state
Changes in biomarkers during treatment
Rate of complete response very good partial response VGPR partial response PR stable disease SD and progressive disease
Determination of ORR PFS and DOR
Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous SC infusion STAR-LLD in combination with dexamethasone and a proteasome inhibitor PI
Secondary Objectives
To assess the immunologic activity of natural killer NK cells and T cells for innate and humoral immunity
To establish the pharmacokinetic PK profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations
To determine pharmacodynamic PD changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide
Evaluate changes in efficacy indicators including objective response rate ORR progression-free survival PFS and duration of response DOR
Exploratory Objective
To assess the impact of STAR-LLD on patient reported symptoms and outcomes Primary Endpoints
The grade frequency and relationship of treatment-emergent adverse events TEAEs including adverse events of special interest AESIs gastrointestinal GI toxicity fatigue hematologic toxicity rash non-infusion site
The observation of dose-limiting toxicities DLTs of STAR-LLD during Cycle 1 Secondary Endpoints
Immune profiles functional assays for NK cell activation and antigen specific T-cell activity
Blood concentrations of lenalidomide at on Day 1 and at steady state
Changes in biomarkers during treatment
Rate of complete response very good partial response VGPR partial response PR stable disease SD and progressive disease
Determination of ORR PFS and DOR
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None