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Spots Global Cancer Trial Database for A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, 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

Contact Details

Name: Janssen Research & Development, LLC Clinical Trial

Affiliation: Janssen Research & Development, LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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