Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT04223661
Status:
WITHDRAWN
Last Update Posted:
2022-12-08
First Post:
2019-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy
Sponsor:
Attaya Suvannasankha
Organization:
Study Overview
Official Title:
Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if using a subject's baseline frailty score to guide the dosing of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite).
Detailed Description:
This is a multi-institution, prospective, single arm Phase II trial of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite) with no blinding or randomization. This study will enroll 44 patients over 36 months.
Primary Objectives:
1. Evaluate Response rate
2. Evaluate Side effects
Secondary Objectives:
1. Evaluate Time on therapy
2. Evaluate Progression free survival
3. Evaluate Time to the next line of therapy
4. Assess Quality of life
Primary Objectives:
1. Evaluate Response rate
2. Evaluate Side effects
Secondary Objectives:
1. Evaluate Time on therapy
2. Evaluate Progression free survival
3. Evaluate Time to the next line of therapy
4. Assess Quality of life
Study Oversight
Has Oversight DMC:
True
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?: