Spots Global Cancer Trial Database for A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
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.
Trial Identification
Brief Title: A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT01564537
Study Description
Brief Summary: The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).
Detailed Description: The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will look at progression free survival (PFS), overall survival (OS) and safety in participants who take ixazomib in addition to lenalidomide and dexamethasone compared to placebo in addition to lenalidomide and dexamethasone. The study enrolled 722 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Ixazomib 4 mg + lenalidomide + dexamethasone * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient + lenalidomide + dexamethasone All participants will receive treatment in 28 day cycles until disease progression or unacceptable toxicity. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 80 months. Participants will make multiple visits to the clinic, and will be contacted every 4 weeks for PFS and every 12 weeks for OS.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas Medical Sciences, Little Rock, Arkansas, United States
Pacific Cancer Medical Center Inc, Anaheim, California, United States
West Contra Costa Healthcare District, Berkeley, California, United States
University of Florida, Gainesville, Florida, United States
Cancer & Blood Disease Center, Lecanto, Florida, United States
Northwest Georgia Oncology Center, Marietta, Georgia, United States
John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
Blood and Cancer Clinic, Fayetteville, North Carolina, United States
Scranton Hematology Oncology, Scranton, Pennsylvania, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Fred Hutchinson Cancer Research, Seattle, Washington, United States
West Virginia University Hospitals and Clinic, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
CHUM Notre-Dame Hospital, Montreal, Quebec, Canada
MUHC Glen Site Cedars Cancer Centre, Montreal, Quebec, Canada
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
