Spots Global Cancer Trial Database for Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma
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Trial Identification
Brief Title: Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma
Official Title: An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of IXAZOMIB (MLN9708), Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment
Study ID: NCT01383928
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
Detailed Description: The drug being tested in this study is called ixazomib. Ixazomib was tested to slow disease progression and improve overall survival in participants who have newly diagnosed multiple myeloma (NDMM). This study looked at the safety, tolerability and response in participants when administered in combination with lenalidomide and low-dose dexamethasone. The study enrolled 64 patients. Participants were assigned to one of the 3 treatment groups: * Phase 1 Ixazomib 3 mg * Phase 1 Ixazomib 3.7 mg * Phase 2 Ixazomib 3 mg All participants were administered with Ixazomib capsules, orally, twice-weekly on Days 1, 4, 8, and 11 along with lenalidomide capsules, orally, once daily on Days 1-14 and dexamethasone, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity. This multi-center trial conducted in the United States. The overall time to participate in this study was 2037 days. Participants will make multiple visits to the clinic, and a final visit after 30 days after last dose of study drug for a follow-up assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Medical Center, Berkeley, California, United States
City of Hope National Medical Center, Duarte, California, United States
Stanford University, Stanford, California, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Associates of Oncology/Hematology PC, Rockville, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Michigan State University, Lansing, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
Mercy St Anne Hospital, Toledo, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
SCRI Tennessee Oncology Nashville, Nashville, Tennessee, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
Virginia Cancer Care Specialist, Fairfax, Virginia, United States
Virginia Cancer Specialists PC, Fairfax, Virginia, United States
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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