NCT00079716

Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma

A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.

Detailed description

This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma. A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	SGN-40 (anti-huCD40 mAb)	0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-08-01
• Completion: 2007-11-01
• First posted: 2004-03-16
• Last updated: 2014-12-18

Locations

5 sites across 1 country: United States