Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 10:29 PM
Study NCT ID:
NCT01101594
Status:
TERMINATED
Last Update Posted:
2021-08-16
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial.
Detailed Description:
In this clinical research trial, hLL1-DOX will be administered on days 1, 4, 8 and 11. This treatment cycle will be repeated every 3 weeks as long as patients continue to tolerate it, for a maximum of 8 treatment cycles (approximately 6 months).
Study Oversight
Has Oversight DMC:
False
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?: