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Closed (no longer recruiting)Last updated: 7 February 2024

This phase I trial is trying to find a safe and tolerable dose of a new intravenous treatment for multiple myeloma patients who have not responded to prior treatmentA Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Clinical summary

Summary

This is a dose escalation study to determine the Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) of WVT078 in adult patients with relapsed and/or refractory Multiple Myeloma (MM). In this trial, WVT078 will be administered intravenously, either alone or in combination with oral WHG626, in a dose escalation schedule.

Conditions

This trial is treating patients with multiple myeloma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Eligibility

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
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Clinical trials have complex eligibility criteria.

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