Track topics on Twitter Track topics that are important to you
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.
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.
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.
Recurrent Plasma Cell Myeloma
Carfilzomib, Dexamethasone, Nivolumab, Pomalidomide, Wild-type Reovirus
Emory University Hospital/Winship Cancer Institute
Not yet recruiting
Published on BioPortfolio: 2018-08-01T14:26:10-0400
This phase Ib trial studies the safety and best dose of wild-type reovirus in combination with bortezomib and dexamethasone and to see how well they work in treating patients with multiple...
This phase II trial studies how well daratumumab and dexamethasone with pomalidomide or carfilzomib work in treating patients with multiple myeloma that has come back. Immunotherapy with d...
This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells...
This is a phase 3 multicenter, randomized, open label study designed to evaluate the clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and dexamethasone (N...
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients w...
The efficacy of daratumumab (DARA) both as a monotherapy and in combination with standard-of-care regimens in multiple myeloma (MM) has been established in clinical trials. This article presents a ret...
Pomalidomide dexamethasone is a standard of care for relapsed multiple myeloma (MM) patients who received at least two prior lines of therapy, including both lenalidomide and proteasome inhibitors (PI...
Predicting the response to treatment with nivolumab and the survival in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) remains a challenge. We investigated whether...
Recurrent Episodes of Nivolumab-Induced Pneumonitis after Nivolumab Discontinuation and the Time Course of Carcinoembryonic Antigen Levels: A Case of a 58-Year-Old Woman with Non-Small Cell Lung Cancer.
The introduction of immune checkpoint inhibitors heralded a new era in the treatment of non-small cell lung cancer. However, nivolumab, an anti-PD-1 antibody, can cause serious adverse events that are...
The immune checkpoint inhibitor, nivolumab, inhibits the programmed death 1 receptor and suppresses the immune resistance of cancer cells. This is a long-term follow-up of a single-arm, open-label, mu...
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.
An anti-inflammatory 9-fluoro-glucocorticoid.
A genus of the family RETROVIRIDAE with type C morphology, that causes malignant and other diseases in wild birds and domestic fowl.
The type species of ORBIVIRUS causing a serious disease in sheep, especially lambs. It may also infect wild ruminants and other domestic animals.
The type species of the genus MARDIVIRUS in the family HERPESVIRIDAE. It is the etiologic agent of MAREK DISEASE, infecting domestic fowl and wild birds.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...