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Proteasome Inhibitor
Reovirus + Carfilzomib + Dexamethasone for Multiple Myeloma
Phase 1
Waitlist Available
Led By Craig C Hofmeister
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential (FCBP) must have a negative pregnancy test and agree to use adequate contraception
Evidence of any end organ damage criteria attributed to the patient's myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of wild-type reovirus given with carfilzomib and dexamethasone to treat patients with relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who've had prior treatments including an immunomodulatory drug and proteasome inhibitor, are not responding to carfilzomib, and have measurable disease. They must be in stable health otherwise, understand the study, agree to avoid certain contacts during treatment, use contraception if applicable, and not donate blood or reproductive cells while on treatment.Check my eligibility
What is being tested?
The trial tests a combination of wild-type reovirus with chemotherapy drugs dexamethasone and carfilzomib. The goal is to find the safest dose that can effectively kill cancer cells without harming normal ones. It's hoped this combo will work better than chemo alone for those whose multiple myeloma has returned or isn't responding.See study design
What are the potential side effects?
Potential side effects include typical reactions from chemotherapy like fatigue, nausea, hair loss; plus unique risks from the virus such as flu-like symptoms. There may also be increased risk of infection due to immune system impacts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I am able to have children, not pregnant, and agree to use birth control.
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My myeloma has caused damage to my organs.
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I can take care of myself but might not be able to do heavy physical work.
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My myeloma has returned or is not responding to treatment and was diagnosed based on specific criteria.
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I do not have HIV, hepatitis B, or hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of combination carfilzomib and wild-type reovirus
Number and severity of adverse events
Number of patients who required dose modifications and/or dose delays in subsequent cycles
+1 moreSecondary outcome measures
Clinical benefit endpoint described as that portion of patients experiencing complete response, very good partial response, or partial response
Duration of response
Number and percentage of subjects experiencing objective response
+4 moreOther outcome measures
Immunologic correlative markers
Side effects data
From 2020 Phase 2 trial β’ 108 Patients β’ NCT0119926392%
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
1Treatment groups
Experimental Treatment
Group I: Treatment (dexamethasone, carfilzomib, Reolysin)Experimental Treatment4 Interventions
Patients receive dexamethasone intravenously (IV), carfilzomib IV over 30 minutes, and Reolysin IV over 60 minutes on days 1, 2, 8, 9, 15, and 16. 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
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1440
Pelareorep
2010
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,359 Total Patients Enrolled
75 Trials studying Anemia
10,808 Patients Enrolled for Anemia
Craig C HofmeisterPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to have children, not pregnant, and agree to use birth control.You have been treated with Reolysin in a clinical trial before.There are too many abnormal plasma cells in your bone marrow.My myeloma has caused damage to my organs.I had a bone marrow transplant more than 90 days ago.I have been treated with specific cancer drugs and my condition is getting worse despite treatment.Your blood counts and chemistry levels need to be within a certain range.I finished my radiation therapy at least 2 weeks ago and have recovered from its side effects.I can take care of myself but might not be able to do heavy physical work.I have POEMS syndrome.My myeloma has returned or is not responding to treatment and was diagnosed based on specific criteria.I agree not to donate blood or reproductive cells while on treatment and for 4 weeks after.I am eligible regardless of my gender, race, or ethnicity.I do not have HIV, hepatitis B, or hepatitis C.I do not have any severe illnesses or recent heart issues that would stop me from following the study's requirements.I am not using alternative medicines that could affect the study's results.I have not had chemotherapy or radiotherapy in the last 2 weeks.I have a tumor that can be measured.My heart's pumping ability might be checked if my medical history suggests it's necessary.I do not have another active cancer that could affect my participation or the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dexamethasone, carfilzomib, Reolysin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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