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Multiple Myeloma

Neoplasms, Plasma Cell

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Pembrolizumab

Dexamethasone

Cyclophosphamide

Bortezomib

Dexamethasone acetate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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).

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.

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).

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

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

For this combination of Pembrolizumab with standard CyBorD, determine the response rate according to IMWG criteria.

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.

Merck Sharp & Dohme LLC

Canadian Myeloma Research Group

Anti-Infective Agents

Bendamustine Hydrochloride

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Subjects will receive Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days with dose escalation from 27, 36, 45 to 56 mg/ m2 . No matter what target dose the subject will receive, days 1 and 2 doses in the first cycle will always be 20 mg/m2, followed by target dose for all subsequent dates and cycles. Bendamustine will be given IV on days 1 and 2 with dose escalation up to 90 mg/m2 and dexamethasone 20 mg orally or intravenously on 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first.

Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle.

Dose escalation is as follows:

-1 \| 60 mg/m2

1. \| 70 mg/m2
2. \| 70 mg/m2
3. \| 90 mg/m2
4. \| 90mg/m2
5. \| 90 mg/m2

Bendamustine

Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days.

Dose Escalation is as follows:

-1 \| 27 mg/m2

1. \| 27 mg/m2
2. \| 36 mg/m2
3. \| 36 mg/m2
4. \| 45 mg/m2
5. \| 56 mg/m2

Carfilzomib

Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.

Siyang Leng, MD

This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma (MM).

Multiple myeloma (MM) is a malignant plasma cell disorder resulting in approximately 11,000 deaths in the United States each year. It is estimated that between 60,000-80,000 people are currently under treatment for refractory or relapsed MM. Prognosis and survival have improved over the last 20 years, but the disease is still universally fatal despite efforts to develop new and more effective chemotherapeutic regimens. Therefore, new regimens need to be developed for patients prior to peripheral blood stem cell transplant and for those unable to tolerate the toxicity of transplant.

Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma

Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

The primary endpoint of this study is dose-limiting toxicity (DLT), to define the recommended phase II dose.

Includes complete response and partial response.

The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the study treatment started).

PFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.

The percentage of people who are still alive.

Total number of AEs observed that are determined to be related to carfilzomib.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) for NDMM NTE	NCT04258683	Multiple Myelom...	Pembrolizumab	18 Years -	Canadian Myeloma Research Group
Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma	NCT02002598	Multiple Myelom...	Bendamustine Carfilzomib Dexamethasone	18 Years -	Columbia University

Spots Global Cancer Trial Database for plasma cell

Every month we try and update this database with for plasma cell cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plasma cell

Every month we try and update this database with for plasma cell cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plasma cell cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.