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Brief Title: A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
Official Title: A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
Study ID: NCT03785184
Brief Summary: This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM). This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope /ID# 212211, Duarte, California, United States
Marin Cancer Care /ID# 208476, Greenbrae, California, United States
University of California, Los Angeles /ID# 208516, Los Angeles, California, United States
Karmanos Cancer Institute /ID# 208805, Detroit, Michigan, United States
Henry Ford Hospital /ID# 208481, Detroit, Michigan, United States
Duke University Hospital /ID# 208306, Durham, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 208121, Pittsburgh, Pennsylvania, United States
Westmead Hospital /ID# 210267, Westmead, New South Wales, Australia
Flinders Centre for Innovation /ID# 210697, Bedford Park, South Australia, Australia
St. Vincents Hosp Melbourne /ID# 210266, Fitzroy, Victoria, Australia
Austin Hospital /ID# 210268, Heidelberg, Victoria, Australia
Monash Medical Centre /ID# 210269, Melbourne, Victoria, Australia
Tom Baker Cancer Centre /ID# 208549, Calgary, Alberta, Canada
Princess Margaret Cancer Centr /ID# 208923, Toronto, Ontario, Canada
Hopital Maisonneuver-Rosemont /ID# 208550, Montreal, Quebec, Canada
McGill Univ HC /ID# 208486, Montreal, Quebec, Canada
Clinica Universitar de Navarra - Pamplona /ID# 209883, Pamplona, Navarra, Comunidad, Spain
Hospital Clinic de Barcelona /ID# 209888, Barcelona, , Spain
Hspital Universitario Gregorio Maranon /ID# 209926, Madrid, , Spain
Clinica Universitar de Navarra - Madrid /ID# 210131, Madrid, , Spain
Hosp Univ 12 de Octubre /ID# 209887, Madrid, , Spain
Hospital Univ Dr. Peset /ID# 209884, Valencia, , Spain
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR