Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    64
  • sponsor
    University of Maryland, Baltimore
Updated on 22 March 2022

Summary

Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma

Description

This is a Phase I/II, open-label study to evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone.

In Phase I, the subjects will be assigned into two arms and there are two dose levels for Belantamab Mafodotin and there are two dose levels of cyclophosphamide in each arm.

In Phase II, once tolerability of the highest planned dose is established, the patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.

Belantamab mafodotin was approved by the U.S. Food and Drug Administration (FDA) on Aug 5, 2020, for treating patients with relapsed/refractory multiple myeloma. Cyclophosphamide and dexamethasone are both approved by the FDA. But the combinations with these three drugs to treat people with relapsed/refractory multiple myeloma has not been approved by the FDA.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment Belantamab Mafodotin, Cyclophosphamide and Dexamethasone
Clinical Study IdentifierNCT04896658
SponsorUniversity of Maryland, Baltimore
Last Modified on22 March 2022

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