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Brief Title: A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title: A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)
Study ID: NCT02616640
Brief Summary: This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen. On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Local Institution - 114, Boston, Massachusetts, United States
Local Institution - 108, Boston, Massachusetts, United States
Local Institution - 115, Boston, Massachusetts, United States
Weill Medical College Of Cornell University, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Froedtert Hospital BMT Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Local Institution - 201, Calgary, Alberta, Canada
Local Institution - 601, Lille, , France
Local Institution - 602, Poitiers Cedex, , France
Local Institution - 603, Toulouse CEDEX 9, , France
Local Institution - 301, Tuebingen, , Germany
Local Institution - 403, Pavia 2, , Italy
Local Institution - 405, Rozzano (MI), , Italy
Local Institution - 401, Torino, , Italy
Local Institution - 702, Amsterdam, , Netherlands
Local Institution - 701, Rotterdam, , Netherlands
Local Institution - 501, Barcelona, , Spain
Local Institution - 504, Madrid, , Spain
Local Institution - 502, Pamplona, , Spain
Local Institution - 505, Valencia, , Spain
Name: Lars Sternas, MD, PhD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR