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A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Official title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2015-05-20
Completion Date
2024-06-03
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
daratumumab
16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
daratumumab
16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and every 8 weeks after Cycle 20. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
daratumumab
16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.
Locations (57)
Little Rock, Arkansas, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Seattle, Washington, United States
Box Hill, Australia
Concord, Australia
Melbourne, Australia
Woodville South, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Brno, Czechia
Hradec Králové, Czechia
Prague, Czechia
Lille, France
Nantes, France
Paris, France
Pierre-Bénite, France
Rennes, France
Berlin, Germany
Chemnitz, Germany
Essen, Germany
Heidelberg, Germany
Mainz, Germany
München, Germany
Tübingen, Germany
Würzburg, Germany
Haifa, Israel
Jerusalem, Israel
Petah Tikva, Israel
Tel Aviv, Israel
Amsterdam, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Nizhny Novgorod, Russia
Petrozavodsk, Russia
Ryazan, Russia
Saint Petersburg, Russia
Ankara, Turkey (Türkiye)
Antalya, Turkey (Türkiye)
Izmir, Turkey (Türkiye)
Samsun, Turkey (Türkiye)
Cardiff, United Kingdom
Nottingham, United Kingdom
Southampton, United Kingdom
Surrey, United Kingdom