NCT01101594

A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	hLL1-DOX (the doxorubicin conjugate of milatuzumab)	hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 \& 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-04-12
• Last updated: 2021-08-16

Locations

5 sites across 1 country: United States