A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide Bortezomib and Dexamethasone (CyBorD) for NDMM NTE

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    20
  • sponsor
    Canadian Myeloma Research Group
Updated on 31 July 2021
dexamethasone
bortezomib

Summary

This is a phase 2A multi-centre, open label, pilot study of pembrolizumab added to the standard first-line therapy of cyclophosphamide, bortezomib and dexamethasone (CyBorD) in newly diagnosed patients with multiple myeloma that are not eligible for autologous stem cell transplantation.

Description

This is a phase 2A, pilot study of pembrolizumab administered in combination with CyBorD in newly diagnosed, transplant ineligible multiple myeloma patients who achieve less than VGPR (according to IMWG criteria) after two cycles of treatment.

Newly diagnosed multiple myeloma patients will start their standard CyBorD treatment with the combination of cyclophosphamide administered at 300 mg/m2 orally, bortezomib administered at 1.5 mg/m2 subcutaneously, and dexamethasone administered orally at 40 mg, all given on days 1, 8, 15 and 22 of each 28-day cycle. Patients not progressing after 2 cycles of CyBorD treatment and achieving less than VGPR by IMWG criteria will be screened for this study. Subjects meeting the eligibility criteria will add pembrolizumab to their standard CyBorD treatment starting with cycle 4 day 1, which will be cycle one of this study treatment. Pembrolizumab in combination with CyBorD will be administered intravenously at 200 mg at day 1 of every 3-week cycle for 8 cycles (24 weeks). CyBorD will be discontinued after 24 weeks and Pembrolizumab will be administered as a single agent at the same dose for an additional 27 cycles (81 weeks).

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, multiple myeloma (mm)
Treatment Pembrolizumab
Clinical Study IdentifierNCT04258683
SponsorCanadian Myeloma Research Group
Last Modified on31 July 2021

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