Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma|
- Adverse events and lab abnormalities. [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
|Study Completion Date:||November 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
Other Name: dacetuzumab
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.
|United States, California|
|James R. Berenson M.D., Inc.|
|West Hollywood, California, United States, 90069|
|United States, Colorado|
|Rocky Mountain Cancer Center|
|Denver, Colorado, United States, 80218|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|New York, New York, United States, 10021|
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Nancy Whiting, PharmD||Seattle Genetics, Inc.|