Spots Global Cancer Trial Database for Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma
Official Title: A Phase Ib/II, Multi-center, Study of Oral LGH447 in Combination With Oral BYL719 in Patients With Relapsed and Refractory Multiple Myeloma
Study ID: NCT02144038
Conditions
Study Description
Brief Summary: This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. This trial never made it to the Phase II part of the this trial.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(SC), Houston, Texas, United States
Seattle Cancer Care Alliance Oncology Dept, Seattle, Washington, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Dept of Onc., Madison, Wisconsin, United States
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Singapore, , Singapore
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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