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Brief Title: Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Official Title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
Study ID: NCT02252172
Brief Summary: The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Detailed Description: This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with newly diagnosed multiple myeloma and who are not candidates for high dose chemotherapy and ASCT. All the eligible participants will be randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16 milligram per kilogram \[mg/kg\]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms. Participants in both treatment arms will continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B (DRd) in this study initially received daratumumab IV formulation; however, following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Participants in Arm A who have sponsor-confirmed disease progression may have the option to receive daratumumab provided by the sponsor (in any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases: Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first). The maximum duration of study will be 7 years after last participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety will be monitored throughout the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Mobile, Alabama, United States
, Glendale, Arizona, United States
, Berkeley, California, United States
, Beverly Hills, California, United States
, El Cajon, California, United States
, Greenbrae, California, United States
, Los Angeles, California, United States
, Oceanside, California, United States
, San Diego, California, United States
, West Hills, California, United States
, Whittier, California, United States
, Denver, Colorado, United States
, Fort Collins, Colorado, United States
, Glenwood Springs, Colorado, United States
, New Haven, Connecticut, United States
, Norwalk, Connecticut, United States
, Washington, District of Columbia, United States
, Boca Raton, Florida, United States
, Boynton Beach, Florida, United States
, Fort Lauderdale, Florida, United States
, Fort Myers, Florida, United States
, Hollywood, Florida, United States
, Jacksonville, Florida, United States
, Lake City, Florida, United States
, Saint Petersburg, Florida, United States
, Weston, Florida, United States
, Atlanta, Georgia, United States
, Augusta, Georgia, United States
, Macon, Georgia, United States
, Marietta, Georgia, United States
, Chicago, Illinois, United States
, Niles, Illinois, United States
, Fort Wayne, Indiana, United States
, Iowa City, Iowa, United States
, Louisville, Kentucky, United States
, Lafayette, Louisiana, United States
, Marrero, Louisiana, United States
, Shreveport, Louisiana, United States
, Annapolis, Maryland, United States
, Baltimore, Maryland, United States
, Frederick, Maryland, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Duluth, Minnesota, United States
, Rochester, Minnesota, United States
, Kansas City, Missouri, United States
, Saint Louis, Missouri, United States
, Omaha, Nebraska, United States
, Hooksett, New Hampshire, United States
, Brick, New Jersey, United States
, Hackensack, New Jersey, United States
, Livingston, New Jersey, United States
, Plainfield, New Jersey, United States
, Somerville, New Jersey, United States
, Summit, New Jersey, United States
, Mineola, New York, United States
, New York, New York, United States
, Rochester, New York, United States
, Asheboro, North Carolina, United States
, Charlotte, North Carolina, United States
, Pinehurst, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Canton, Ohio, United States
, Cleveland, Ohio, United States
, Columbus, Ohio, United States
, Bend, Oregon, United States
, Bethlehem, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Spartanburg, South Carolina, United States
, Sioux Falls, South Dakota, United States
, Chattanooga, Tennessee, United States
, Nashville, Tennessee, United States
, Arlington, Texas, United States
, Edinburg, Texas, United States
, Fort Sam Houston, Texas, United States
, Fort Worth, Texas, United States
, Houston, Texas, United States
, Plano, Texas, United States
, San Antonio, Texas, United States
, Ogden, Utah, United States
, Seattle, Washington, United States
, Spokane, Washington, United States
, Tacoma, Washington, United States
, Box Hill, , Australia
, Fitzroy, , Australia
, Footscray, , Australia
, Kogarah, , Australia
, Kurralta Park, , Australia
, Nedlands, , Australia
, New South Wales, , Australia
, Woodville, , Australia
, Woolloongabba N/a, , Australia
, Innsbruck, , Austria
, Linz, , Austria
, Salzburg, , Austria
, Wien N/a, , Austria
, Wien Wien, , Austria
, Brugge, , Belgium
, Brussels, , Belgium
, Brussel, , Belgium
, Haine-saint-paul, LA Louviere, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Calgary, Alberta, Canada
, Toronto, Ontario, Canada
, Greenfield Park, Quebec, Canada
, Montreal, Quebec, Canada
, Montréal, Quebec, Canada
, N/a N/a, , Canada
, Nova Scotia, , Canada
, Quebec, , Canada
, Aarhus C, , Denmark
, Odense, , Denmark
, Vejle, , Denmark
, Amiens N/a Picardie, , France
, Angers, , France
, Bayonne Cedex, , France
, Bretagne, , France
, Caen, , France
, Cergy Pontoise, , France
, Chalons Sur Saone, , France
, Clermont-Ferrand, , France
, Creteil, , France
, Dijon, , France
, Dunkerque Cedex 1, , France
, Grenoble Cedex 9, , France
, La Roche sur Yon Cedex 9, , France
, Le Chesnay Cedex, , France
, Le Mans, , France
, Lille Cedex, , France
, Lille, , France
, Limoges, , France
, Lyon, Pierre-Benite, , France
, Marseille Cedex 9, , France
, Metz-Tessy, , France
, Montivilliers, , France
, Montpellier, , France
, Mulhouse, , France
, Nantes, , France
, Nice N/a, , France
, Paris Cedex 12, , France
, Paris, 75, , France
, Paris, , France
, PERIGUEUX cedex, , France
, Perpignan, , France
, Pessac, , France
, Poitiers, , France
, Reims, , France
, Rennes, , France
, Rouen Cedex, , France
, Saint Brieuc Cedex 1, , France
, Saint Priest en Jarez, , France
, St Malo Cedex, , France
, St Quentin Cedex, , France
, Strasbourg, , France
, Toulouse Cedex 9, , France
, TOURS Cedex 9, , France
, Vandoeuvre Les Nancy, , France
, Aschaffenburg, , Germany
, Bad Berka, , Germany
, Bonn, , Germany
, Braunschweig, , Germany
, Dresden, , Germany
, Essen, , Germany
, Frankfurt, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Hessen, , Germany
, Kiel, , Germany
, Koblenz, , Germany
, Mainz, , Germany
, Mannheim, , Germany
, Rostock, , Germany
, Schwerin, , Germany
, Stuttgart, , Germany
, Tuebingen, , Germany
, Ulm, , Germany
, Villingen-Schwenningen, , Germany
, Dublin, , Ireland
, Galway, , Ireland
, Hadera, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Nahariya, , Israel
, Petah Tikva, , Israel
, Tel-Aviv, , Israel
, Hilversum, , Netherlands
, Hoofddorp, , Netherlands
, Rotterdam, , Netherlands
, Tilburg, , Netherlands
, Falun, , Sweden
, Göteborg, , Sweden
, Halmstad, , Sweden
, Helsingborg, , Sweden
, Huddinge, , Sweden
, Lulea, , Sweden
, Lund, , Sweden
, Stockholm, , Sweden
, Örebro, , Sweden
, Aberdeen, , United Kingdom
, Canterbury, , United Kingdom
, Dundee, , United Kingdom
, Leeds, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Nottingham, , United Kingdom
, Oxford, , United Kingdom
, Plymouth, Devon, , United Kingdom
, Southampton, , United Kingdom
, Truro, , United Kingdom
, Wolverhampton, , United Kingdom
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR