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Proteasome Inhibitor

Pelareorep for Multiple Myeloma

Phase 1
Waitlist Available
Led By Craig Hofmeister, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arm ONE only: Patients must be carfilzomib naive and have received ≥ 2 prior lines of therapy and must have included an IMiD, proteasome inhibitor, and anti-cluster of differentiation 38 (CD38) antibody as defined below
- Progressive disease or clinical relapse at the time of study entry as defined by IMWG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of protocol therapy up to 3 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of a modified virus given with drugs that are already used to treat relapsed multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of protocol therapy up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of protocol therapy up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLT of 3-drug regimen evaluated according to NCI CTCAE version 5.0
Dose-limiting toxicity (DLT) of 4-drug regimen evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Maximum tolerated dose (MTD) of 4-drug regimen
Secondary outcome measures
Overall survival
Progression-free survival
Time to progression

Side effects data

From 2020 Phase 2 trial • 108 Patients • NCT01199263
90%
Anemia
83%
Fatigue
73%
White Blood Cell Decreased
73%
Nausea
73%
Alopecia
63%
Peripheral Sensory Neuropathy
58%
Constipation
52%
Neutrophil Count Decreased
50%
Dyspnea
48%
Abdominal Pain
46%
Anorexia
44%
Hypoalbuminemia
42%
Diarrhea
42%
Vomiting
38%
Depression
38%
Edema Limbs
35%
Hyperglycemia
33%
Hypocalcemia
31%
Hypertension
31%
Hyponatremia
27%
Urinary Tract Infection
27%
Creatinine Increased
25%
Arthralgia
25%
Cough
23%
Hypomagnesemia
23%
Aspartate Aminotransferase Increased
23%
Platelet Count Decreased
23%
Insomnia
23%
Headache
21%
Bloating
21%
Hypokalemia
21%
Mucositis Oral
21%
Anxiety
21%
Hot Flashes
21%
Rash Maculo-Papular
19%
Dehydration
19%
Pain
19%
Generalized Muscle Weakness
19%
Alkaline Phosphatase Increased
19%
Dizziness
17%
Back Pain
17%
Bone Pain
17%
Urinary Frequency
15%
Blurred Vision
15%
Fever
15%
Alanine Aminotransferase Increased
15%
Nasal Congestion
15%
Abdominal Distension
13%
Dyspepsia
13%
Pain In Extremity
13%
Hypotension
13%
Tinnitus
13%
Lymphocyte Count Decreased
13%
Non-Cardiac Chest Pain
13%
Small Intestinal Obstruction
13%
Pruritus
10%
Nail Discoloration
10%
Localized Edema
10%
Ascites
10%
Sore Throat
10%
Postnasal Drip
10%
Allergic Rhinitis
10%
Urinary Urgency
10%
Urinary Tract Pain
8%
Chills
8%
Chest Wall Pain
8%
Nail Loss
8%
Weight Loss
8%
Hypernatremia
8%
Urinary Incontinence
8%
Ear Pain
8%
Weight Gain
8%
Activated Partial Thromboplastin Time Prolonged
8%
Dysgeusia
8%
Flushing
8%
Thromboembolic Event
6%
Hypophosphatemia
6%
Hyperkalemia
6%
Hypoglycemia
6%
Hearing Impaired
6%
Fall
6%
Blood Bilirubin Increased
6%
Palpitations
6%
Myalgia
6%
Proteinuria
4%
Hypermagnesemia
4%
Arthritis
4%
Esophagitis
4%
Gastritis
4%
Upper Respiratory Infection
4%
Hematuria
4%
Gastroesophageal Reflux Disease
4%
Allergic Reaction
4%
Urinary Retention
4%
Hypertriglyceridemia
4%
Cataract
4%
Dry Mouth
4%
Toothache
4%
Rectal Hemorrhage
4%
Sepsis
4%
Sinusitis
4%
Esophageal Pain
4%
Skin Infection
4%
Restlessness
4%
Sinus Tachycardia
4%
Chest Pain - Cardiac
4%
Flu Like Symptoms
4%
Bruising
4%
Inr Increased
4%
Tremor
4%
Peripheral Motor Neuropathy
4%
Memory Impairment
4%
Dysphasia
4%
Cognitive Disturbance
4%
Confusion
4%
Pleural Effusion
4%
Dry Skin
4%
Vaginal Hemorrhage
4%
Eye Pain
4%
Flank Pain
4%
Rash Acneiform
2%
Rectal Pain
2%
Acidosis
2%
Dysphagia
2%
Hyperuricemia
2%
Urinary Tract Obstruction
2%
Peritoneal Infection
2%
Soft Tissue Infection
2%
Floaters
2%
Conjunctivitis
2%
Esophageal Hemorrhage
2%
Lung Infection
2%
Hypercalcemia
2%
Rectal Mucositis
2%
Nail Ridging
2%
Extraocular Muscle Paresis
2%
Ileus
2%
Colitis
2%
Malaise
2%
Infusion Related Reaction
2%
Neck Pain
2%
Colonic Perforation
2%
Leukocytosis
2%
Neoplasms Benign, Malignant And Unspecified (Incl
2%
Acute Kidney Injury
2%
Acute Coronary Syndrome
2%
Flashing Lights
2%
Facial Pain
2%
Edema Face
2%
Bronchial Infection
2%
Fracture
2%
Sinus Pain
2%
Akathisia
2%
Agitation
2%
Breast Pain
2%
Epistaxis
2%
Stoma Site Infection
2%
Edema Trunk
2%
Bullous Dermatitis
2%
Esophageal Infection
2%
Cholesterol High
2%
Urine Output Decreased
2%
Vaginal Dryness
2%
Pelvic Pain
2%
Lymphedema
2%
Vaginal Discharge
2%
Gastric Hemorrhage
2%
Oral Pain
2%
Otitis Media
2%
Papulopustular Rash
2%
Muscle Weakness Lower Limb
2%
Palmar-Plantar Erythrodysesthesia Syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Paclitaxel)
Arm II (Paclitaxel and Wild-type Reovirus)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3 (expansion)Experimental Treatment4 Interventions
Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep 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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm 2Experimental Treatment4 Interventions
Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep 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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm 1Experimental Treatment3 Interventions
Patients receive dexamethasone 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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelareorep
2010
Completed Phase 2
~150
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

University of UtahOTHER
1,088 Previous Clinical Trials
1,728,326 Total Patients Enrolled
6 Trials studying Multiple Myeloma
253 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,742 Total Patients Enrolled
24 Trials studying Multiple Myeloma
1,905 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,513 Total Patients Enrolled
84 Trials studying Multiple Myeloma
29,655 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT03605719 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate other research initiatives that have incorporated Pelareorep?

"Pelareorep was initially examined in 2002 by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. At present, 1387 studies have been concluded and 1275 are still ongoing - a hefty portion of these trials being conducted from Salt Lake City."

Answered by AI

How many participants have enrolled in the experiment?

"This research is no longer accepting patients. It was first shared on October 24th 2018 and had its latest update on May 27th 2022. If you are searching for other studies, there are 807 trials targeting neoplasms or plasma cells that still require participants, along with 1275 calling for people to take part in Pelareorep testing."

Answered by AI

What are the known possible risks associated with Pelareorep?

"The scarcity of evidence supporting the safety and efficacy of Pelareorep has caused our team at Power to assign it a score of 1 on a scale from 1 to 3."

Answered by AI

Is this experiment accepting new participants?

"In keeping with the information available on clinicaltrials.gov, it is apparent that this particular trial has ceased enrollment. It was originally posted in October 2018 and last updated May 27th 2022; however, there are currently 2,082 other trials actively recruiting participants."

Answered by AI

In what contexts is Pelareorep typically employed?

"Pelareorep is an effective remedy for ophthalmia, sympathetic eye diseases, branch retinal vein occlusions and macular edema."

Answered by AI
~4 spots leftby Mar 2025