Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT02477891
- Status
- Approved For Marketing
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — DRUGParticipants 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.
Study Details
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.
Key Dates
- Status verified
- Jan 2019
Locations (41)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Phoenix | Arizona | - | - |
| - | Little Rock | Arkansas | - | - |
| - | Duarte | California | - | - |
| - | Fountain Valley | California | - | - |
| - | Gilroy | California | - | - |
| - | Greenbrae | California | - | - |
| - | Los Angeles | California | - | - |
| - | West Hollywood | California | - | - |
| - | Denver | Colorado | - | - |
| - | New Haven | Connecticut | - | - |
| - | Jacksonville | Florida | - | - |
| - | Ocala | Florida | - | - |
| - | West Palm Beach | Florida | - | - |
| - | Atlanta | Georgia | - | - |
| - | Boise | Idaho | - | - |
| - | Chicago | Illinois | - | - |
| - | Indianapolis | Indiana | - | - |
| - | Iowa City | Iowa | - | - |
| - | Topeka | Kansas | - | - |
| - | Louisville | Kentucky | - | - |
| - | Baltimore | Maryland | - | - |
| - | Bethesda | Maryland | - | - |
| - | Boston | Massachusetts | - | - |
| - | Detroit | Michigan | - | - |
| - | St Louis | Missouri | - | - |
| - | Great Falls | Montana | - | - |
| - | Omaha | Nebraska | - | - |
| - | Flemington | New Jersey | - | - |
| - | Hackensack | New Jersey | - | - |
| - | New Brunswick | New Jersey | - | - |
| - | Buffalo | New York | - | - |
| - | New York | New York | - | - |
| - | Chapel Hill | North Carolina | - | - |
| - | Charlotte | North Carolina | - | - |
| - | Corvallis | Oregon | - | - |
| - | Hershey | Pennsylvania | - | - |
| - | Charleston | South Carolina | - | - |
| - | Greenville | South Carolina | - | - |
| - | Dallas | Texas | - | - |
| - | Houston | Texas | - | - |
| - | Fairfax | Virginia | - | - |
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