Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00079716|
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : December 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: SGN-40 (anti-huCD40 mAb)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||November 2007|
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
- Adverse events and lab abnormalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079716
|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.|