Pembrolizumab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Los Angeles County-USC Medical Center, Los Angeles, CA
Multiple Myeloma+3 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 modified in the laboratory, such as pelareorep, may be able to kill cancer cells without damaging normal cells. Giving the combination of bortezomib, dexamethasone, and pembrolizumab with pelareorep may work better in treating patient with multiple myeloma.

Eligible Conditions

  • Refractory Plasma Cell Myeloma
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Up to 3 years

Day 21
Incidence of dose-limiting toxicities (DLTs) (Phase 1B)
Day 90
Incidence of adverse events (Phase 2)
Severity of serious adverse events (Phase 2)
Up to 3 years
CD4 and CD8 T-cell reactivity (Phase 1B, Phase 2)
Changes in gene expression (Phase 1B, Phase 2)
Changes in the T cell repertoire within peripheral blood and the TME (Phase 1B, Phase 2)
Changes in the expression of immune-related biomarkers (Phase 1B, Phase 2)
Duration of response (DOR) (Phase 2)
Number of effector T-cells and resting T-cells (Phase 1B, Phase 2)
ORR (CR + PR) (Phase 1B)
Overall response rate (ORR) (complete response [CR] + partial response [PR]) (Phase 2)
Overall survival (OS) (Phase 2)
PELA in combination with different therapies (Phase 1B, Phase 2)
Progression-free survival (PFS) (Phase 2)
Day 30
Incidence and severity of adverse events (AEs) (Phase 1B)

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Cohort I (standard therapy)
1 of 2
Cohort II (standard therapy, pelareorep)
1 of 2
Experimental Treatment

42 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

Cohort I (standard therapy)Experimental Group · 3 Interventions: Dexamethasone, Bortezomib, Pembrolizumab · Intervention Types: Drug, Drug, Biological
Cohort II (standard therapy, pelareorep)Experimental Group · 4 Interventions: Dexamethasone, Bortezomib, Pelareorep, Pembrolizumab · Intervention Types: Drug, Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2420
Bortezomib
2005
Completed Phase 2
~1330
Pelareorep
2010
Completed Phase 2
~110
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Los Angeles County-USC Medical Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2011First Recorded Clinical Trial
5 TrialsResearching Multiple Myeloma
53 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,418 Total Patients Enrolled
553 Trials studying Multiple Myeloma
192,611 Patients Enrolled for Multiple Myeloma
University of Southern CaliforniaLead Sponsor
813 Previous Clinical Trials
1,360,624 Total Patients Enrolled
3 Trials studying Multiple Myeloma
127 Patients Enrolled for Multiple Myeloma
Kevin R Kelly, MDPrincipal InvestigatorUniversity of Southern California

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 7 months after the last dose of study treatment.
You have relapsed or refractory multiple myeloma (MM) after at least 3 previous lines of therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.