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Brief Title: A Study of WVT078 in Patients With Multiple Myeloma (MM)
Official Title: A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT04123418
Brief Summary: The design of a phase I, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in patients relapses and/or refractory Multiple Myeloma (MM)
Detailed Description: This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Emory University School of Medicine/Winship Cancer Institute ., Atlanta, Georgia, United States
University of Wisconsin, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Bunkyo ku, Tokyo, Japan
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Santander, Cantabria, Spain
Novartis Investigative Site, Barcelona, , Spain