NCT03605719

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

Completed Phase 1 Last updated 6 October 2023

What this trial tests

Phase 1 trial testing Carfilzomib in Recurrent Plasma Cell Myeloma in 23 participants. Completed in 10 October 2022.

Timeline

24 October 2018

Primary endpoint
10 October 2022

10 October 2022

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	24 October 2018
Primary completion	10 October 2022
Estimated completion	10 October 2022
Sites	2 locations across United States

Drugs / interventions tested

• Carfilzomib (carfilzomib) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Pelareorep — full drug profile →

Conditions studied

• Recurrent Plasma Cell Myeloma — all drugs for Recurrent Plasma Cell Myeloma →

Sponsor

Emory University

Who can join

18 and older, any sex, with Recurrent Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of wild-type reovirus (pelareorep) when given together with dexamethasone, carfilzomib, and nivolumab in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. A virus, called pelareorep, 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 pelareorep may work better in treating patients with multiple myeloma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
2. Oncolytic Viruses for Cancer Therapy: Barriers and Recent Advances.
   Zheng M, Huang J, Tong A, Yang H. · · 2019 · cited 213× · PMID 31872046 · DOI 10.1016/j.omto.2019.10.007
3. Engineering strategies to enhance oncolytic viruses in cancer immunotherapy.
   Tian Y, Xie D, Yang L. · · 2022 · cited 199× · PMID 35387984 · DOI 10.1038/s41392-022-00951-x
4. Recent advances of oncolytic virus in cancer therapy.
   Mondal M, Guo J, He P, Zhou D. · · 2020 · cited 154× · PMID 32078405 · DOI 10.1080/21645515.2020.1723363
5. Combining Oncolytic Viruses With Cancer Immunotherapy: Establishing a New Generation of Cancer Treatment.
   Shi T, Song X, Wang Y, Liu F, et al · · 2020 · cited 134× · PMID 32411132 · DOI 10.3389/fimmu.2020.00683
6. Oncolytic Viruses: Newest Frontier for Cancer Immunotherapy.
   Rahman MM, McFadden G. · · 2021 · cited 107× · PMID 34771615 · DOI 10.3390/cancers13215452
7. Past, Present and Future of Oncolytic Reovirus.
   Müller L, Berkeley R, Barr T, Ilett E, et al · · 2020 · cited 97× · PMID 33142841 · DOI 10.3390/cancers12113219
8. Improving cancer immunotherapy by rationally combining oncolytic virus with modulators targeting key signaling pathways.
   Zhu Z, McGray AJR, Jiang W, Lu B, et al · · 2022 · cited 74× · PMID 36221123 · DOI 10.1186/s12943-022-01664-z