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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
Be older than 18 years old
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

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
92%
Anemia
85%
Nausea
85%
Fatigue
81%
White Blood Cell Decreased
75%
Neutrophil Count Decreased
71%
Constipation
69%
Alopecia
63%
Chills
63%
Peripheral Sensory Neuropathy
58%
Platelet Count Decreased
58%
Dyspnea
52%
Fever
52%
Anorexia
52%
Diarrhea
48%
Hypoalbuminemia
46%
Abdominal Pain
46%
Vomiting
40%
Pain
38%
Hypertension
37%
Headache
37%
Hyperglycemia
35%
Flu Like Symptoms
35%
Cough
31%
Mucositis Oral
31%
Hypocalcemia
31%
Depression
29%
Hyponatremia
29%
Back Pain
29%
Edema Limbs
27%
Hypomagnesemia
27%
Creatinine Increased
25%
Myalgia
23%
Dizziness
23%
Insomnia
21%
Anxiety
21%
Urinary Tract Infection
19%
Bloating
19%
Arthralgia
19%
Generalized Muscle Weakness
19%
Nasal Congestion
17%
Hypokalemia
17%
Urinary Frequency
15%
Pruritus
15%
Non-Cardiac Chest Pain
15%
Aspartate Aminotransferase Increased
15%
Alkaline Phosphatase Increased
13%
Dehydration
13%
Pain In Extremity
13%
Hypotension
13%
Epistaxis
13%
Hot Flashes
12%
Rash Maculo-Papular
12%
Blurred Vision
12%
Urinary Tract Pain
12%
Alanine Aminotransferase Increased
12%
Flushing
10%
Sinus Tachycardia
10%
Neoplasms Benign, Malignant And Unspecified (Incl
10%
Atrial Fibrillation
10%
Abdominal Distension
10%
Sinusitis
10%
Hypophosphatemia
10%
Dry Skin
10%
Nail Loss
10%
Hyperkalemia
10%
Pleural Effusion
10%
Productive Cough
10%
Nail Discoloration
10%
Ascites
8%
Allergic Rhinitis
8%
Hoarseness
8%
Small Intestinal Obstruction
8%
Dysphagia
8%
Hypermagnesemia
8%
Lymphocyte Count Decreased
8%
Postnasal Drip
8%
Urinary Incontinence
8%
Weight Loss
8%
Thromboembolic Event
6%
Stomach Pain
6%
Enterocolitis Infectious
6%
Blood Bilirubin Increased
6%
Edema Face
6%
Vaginal Infection
6%
Weight Gain
6%
Sore Throat
6%
Hematuria
6%
Dysgeusia
6%
Inr Increased
6%
Activated Partial Thromboplastin Time Prolonged
6%
Hypoxia
6%
Localized Edema
4%
Lung Infection
4%
Intra-Abdominal Hemorrhage
4%
Flashing Lights
4%
Chest Pain - Cardiac
4%
Palpitations
4%
Tinnitus
4%
Gastroesophageal Reflux Disease
4%
Malaise
4%
Infusion Related Reaction
4%
Allergic Reaction
4%
Upper Respiratory Infection
4%
Skin Infection
4%
Hypoglycemia
4%
Sinus Disorder
4%
Confusion
4%
Chest Wall Pain
4%
Neck Pain
4%
Syncope
4%
Ear Pain
4%
Peripheral Motor Neuropathy
4%
Hyperhidrosis
4%
Acute Kidney Injury
2%
Infusion Site Extravasation
2%
Febrile Neutropenia
2%
Sinus Bradycardia
2%
Myocardial Infarction
2%
Purpura
2%
Gastritis
2%
Cataract
2%
Vaginal Hemorrhage
2%
Retinopathy
2%
Floaters
2%
Sepsis
2%
Intracranial Hemorrhage
2%
Ventricular Tachycardia
2%
Hip Fracture
2%
Gallbladder Pain
2%
Pharyngitis
2%
Dyspepsia
2%
Rectal Hemorrhage
2%
Oral Pain
2%
Flatulence
2%
Enterocolitis
2%
Wound Infection
2%
Anal Fistula
2%
Salivary Gland Infection
2%
Gum Infection
2%
Upper Gastrointestinal Hemorrhage
2%
Fecal Incontinence
2%
Mucosal Infection
2%
Conjunctivitis Infective
2%
Oral Hemorrhage
2%
Injection Site Reaction
2%
Gastroparesis
2%
Hepatobiliary Disorders - Other
2%
Gait Disturbance
2%
Pelvic Pain
2%
Gallbladder Obstruction
2%
Pulmonary Hypertension
2%
Nail Infection
2%
Nail Ridging
2%
Suicidal Ideation
2%
Acidosis
2%
Muscle Weakness Lower Limb
2%
Lymphedema
2%
Pain Of Skin
2%
Hypernatremia
2%
Respiratory Failure
2%
Palmar-Plantar Erythrodysesthesia Syndrome
2%
Sneezing
2%
Presyncope
2%
Paresthesia
2%
Akathisia
2%
Hypercalcemia
2%
Lethargy
2%
Arthritis
2%
Urinary Urgency
2%
Facial Muscle Weakness
2%
Ataxia
2%
Movements Involuntary
2%
Urinary Tract Obstruction
2%
Erythema Multiforme
2%
Superficial Thrombophlebitis
2%
Pneumothorax
2%
Watering Eyes
2%
Laryngitis
2%
Bladder Infection
2%
Postoperative Hemorrhage
2%
Fall
2%
Bruising
2%
Depressed Level Of Consciousness
2%
Cognitive Disturbance
2%
Pneumonitis
2%
Sleep Apnea
2%
Wheezing
2%
Adrenal Insufficiency
2%
Burn
2%
Chronic Kidney Disease
2%
Vaginal Pain
2%
Agitation
2%
Skin And Subcutaneous Tissue Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Paclitaxel and Wild-type Reovirus)
Arm I (Paclitaxel)

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
1,103 Previous Clinical Trials
1,781,694 Total Patients Enrolled
6 Trials studying Multiple Myeloma
253 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,727 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,402 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,983 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,956 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
Recent research and studies
clinicaltrials.govStudy
Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma
Craig Hofmeister 2018. "Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03605719.
~4 spots leftby May 2025
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