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Dexamethasone, Carfilzomib, Nivolumab, & Pomalidomide With Reovirus for Relapsed/Refractory Multiple Myeloma

2018-08-01 14:26:10 | BioPortfolio

Summary

This phase I trial studies the side effects and best dose of wild-type reovirus when given together with dexamethasone, carfilzomib, and nivolumab with or without pomalidomide in treating participants with multiple myeloma that has come back. Drugs used in chemotherapy, such as, dexamethasone and pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving dexamethasone, carfilzomib, and nivolumab with wild-type reovirus or wild-type reovirus and pomalidomide may work better in treating participants with multiple myeloma.

Description

PRIMARY OBJECTIVES:

I. Identify maximum tolerated dose of wild-type reovirus (pelareorep) in combination with other antineoplastic agents.

II. Identify whether the combination of carfilzomib and nivolumab lead to a safety profile different than what has been reported with either agent independently.

III. Identify safety for 5-drug regimen containing programmed cell death protein 1 (PD1) inhibitor & pelareorep-based combination.

SECONDARY OBJECTIVES:

I. Assess the relative roles of immune-mediated and direct cytotoxic myeloma cell killing.

II. Understand the clinical benefit of nivolumab in PD-L1 positive multiple myeloma (MM) cells.

OUTLINE: This is a dose-escalation study of wild-type reovirus. Participants are assigned to 1 of 3 arms.

ARM I: Participants receive dexamethasone intravenously (IV) on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Participants receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, wild-type reovirus IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III: Participants receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, wild-type reovirus IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, nivolumab IV over 30 minutes on days 1 and 15, and pomalidomide orally (PO) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up for 4 weeks.

Study Design

Conditions

Recurrent Plasma Cell Myeloma

Intervention

Carfilzomib, Dexamethasone, Nivolumab, Pomalidomide, Wild-type Reovirus

Location

Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
United States
30322

Status

Not yet recruiting

Source

Emory University

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-08-01T14:26:10-0400

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Medical and Biotech [MESH] Definitions

Animals considered to be wild or feral or not adapted for domestic use. It does not include wild animals in zoos for which ANIMALS, ZOO is available.

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A genus of the family RETROVIRIDAE with type C morphology, that causes malignant and other diseases in wild birds and domestic fowl.

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