The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Official Title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma
Study ID: NCT02316106
Brief Summary: The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Detailed Description: This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM \[ie, early disease without any symptoms\]). Participants will be randomized (assigned by chance) to one of 3 treatment groups (arm A \[long intense\], arm B \[intermediate\] and arm C \[short intense\]) to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. For participants in Arm A (long intense) and Arm B (intermediate), there is a possibility to extend treatment with IV daratumumab (Q8W) after the end of Cycle 20 if, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade \>=3 treatment related toxicity, and at least stable disease has been achieved. 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). The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 7 years after the last participant enrolled receives a first dose of study drug. 'Disease assessment will be performed locally per Standard of Care.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
, Saint 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 Kralove, , Czechia
, Praha 2, , Czechia
, Lille, , France
, Nantes, , France
, Paris, , France
, Pierre Benite, , France
, Rennes Cedex, , France
, Berlin, , Germany
, Chemnitz, , Germany
, Essen, , Germany
, Heidelberg, , Germany
, Mainz, , Germany
, München, , Germany
, Tuebingen, , Germany
, Würzburg, , Germany
, Haifa, , Israel
, Jerusalem, , Israel
, Petah Tikva, , Israel
, Tel Aviv, , Israel
, Amsterdam, , Netherlands
, Rotterdam, , Netherlands
, Utrecht, , Netherlands
, Nizhny Novgorod, , Russian Federation
, Petrozavodsk, , Russian Federation
, Ryazan, , Russian Federation
, St-Petersburg, , Russian Federation
, Ankara, , Turkey
, Antalya, , Turkey
, Izmir, , Turkey
, Samsun, , Turkey
, Cardiff, , United Kingdom
, Nottingham, , United Kingdom
, Southampton, , United Kingdom
, Surrey, , United Kingdom
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR