A Study of WVT078 in Patients With Multiple Myeloma (MM)

  • STATUS
    Recruiting
  • End date
    Dec 8, 2023
  • participants needed
    90
  • sponsor
    Novartis Pharmaceuticals
Updated on 20 September 2021
proteasome inhibitor
refractory multiple myeloma
immunomodulatory imide drug

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)

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment WVT078, WHG626
Clinical Study IdentifierNCT04123418
SponsorNovartis Pharmaceuticals
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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