Status:
TERMINATED
A Study of WVT078 in Patients With Multiple Myeloma (MM)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma (MM)
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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/...
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 com...
Eligibility Criteria
Inclusion
- Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
Exclusion
- Use of systemic chronic steroid therapy (\>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment
- Malignant disease other than being treated on this study
- Active known or suspected autoimmune disease
- Impaired cardiac function or clinically significant cardiac disease
- Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter
- Active central nervous system involvement by malignancy or presence of symptomatic CNS metasteses
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04123418
Start Date
December 5 2019
End Date
December 2 2024
Last Update
December 24 2025
Active Locations (12)
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1
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
University Of Wisconsin
Madison, Wisconsin, United States, 53792
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
4
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004