The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.
This is a multicenter, open-label, early access treatment protocol of single-agent daratumumab in subjects with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD, who reside in areas where daratumumab is not commercially available or available through another protocol, who have not been enrolled in another daratumumab study, and who are not eligible for or who do not have access to enrollment in another ongoing clinical study of daratumumab. The study will have three phases: Screening phase (30 days prior to first dose of study drug), treatment phase (until documented progression, unacceptable toxicity, or study end), End of Treatment (30 days after last dose of study drug). Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion. Participants will primarily be assessed for overall response rate. Safety will be monitored throughout the study.
Study Type
EXPANDED_ACCESS
Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Duarte, California, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Gilroy, California, United States
Unnamed facility
Greenbrae, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
West Hollywood, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
New Haven, Connecticut, United States
...and 69 more locations