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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Lars Sternas, MD, PhD

Affiliation: Celgene Corporation

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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