A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) for NDMM NTE
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|ClinicalTrials.gov Identifier: NCT04258683|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Pembrolizumab||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Multiple Myeloma Patients Not Eligible For Autologous Stem Cell Transplantation|
|Actual Study Start Date :||February 17, 2021|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: Pembrolizumab with CyBorD
This will be a single arm study of pembrolizumab with cyclophosphamide, bortezomib and dexamethasone (CyBorD).
Patients not progressing after 2 cycles of CyBorD treatment and achieving less than VGPR by IMWG criteria will be screened to receive pembrolizumab intravenously at 200mg at day 1 of every 3-week cycle for 8 cycles (24 weeks) starting Cycle 4 of CyBorD. 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).
Other Name: Keytruda
- Overall response rate (ORR) [ Time Frame: 36 months from study registration ]For this combination of Pembrolizumab with standard CyBorD, determine the response rate according to IMWG criteria.
- Safety (adverse events) of Pembrolizumab in combination with CyBorD [ Time Frame: 36 months from study registration ]For this combination of Pembrolizumab with standard CyBorD, determine the incidence rates for adverse events using NCI CTCAE v5.0 grading. Generate a summary table for each term and body system, in addition to serious adverse events, subjects with related adverse events, subject deaths, and subjects who discontinue due to adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258683
|Contact: Aniba Khan||416-477-9849 ext firstname.lastname@example.org|
|Winnipeg, Manitoba, Canada, R3E0V9|
|Contact: Jo-Ann Weir 204-787-4513 email@example.com|
|Principal Investigator: Rami Kotb, MD|
|Canada, New Brunswick|
|The Moncton Hospital||Recruiting|
|Moncton, New Brunswick, Canada, E1C6Z8|
|Contact: Sahira Husain 506-870-2832 sahira.husain@horizonNB.ca|
|Principal Investigator: Nizar A Samad, MD|
|CIUSSS de l'Estrie-CHUS||Recruiting|
|Sherbrooke, Quebec, Canada, J1H5N4|
|Contact: Anick Champoux 819-346-1110 Anick.firstname.lastname@example.org|
|Principal Investigator: Michael Pavic, MD|
|Allan Blair Cancer Centre||Recruiting|
|Regina, Saskatchewan, Canada, S4T7T1|
|Contact: Gail Nistor 306-766-2010 email@example.com|
|Principal Investigator: Ibraheem Othman, MD|