This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
Up to 25 mg daily of a 21-day cycle.
40 mg administered weekly.
Rocky Mountain Cancer Center
Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Adverse events and lab abnormalities.
Time frame: Within 3 weeks of final infusion of SGN-40
Best clinical response, progression-free survival, and overall survival.
Time frame: Study duration
PK profile.
Time frame: Within 3 weeks of final infusion of SGN-40
Anti-drug antibody immune responses.
Time frame: Within 3 weeks of final infusion of SGN-40
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Medical College of Cornell University
New York, New York, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Baylor University Medical Center
Dallas, Texas, United States