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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 “Yes” for the criteria below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

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 more

Secondary 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 more

Other outcome measures

Immunologic correlative markers

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

Hoarseness

Small Intestinal Obstruction

Dysphagia

Allergic Rhinitis

Hypermagnesemia

Lymphocyte Count Decreased

Postnasal Drip

Urinary Incontinence

Weight Loss

Thromboembolic Event

Stomach Pain

Enterocolitis Infectious

Blood Bilirubin Increased

Edema Face

Vaginal Infection

Weight Gain

Sore Throat

Hematuria

Dysgeusia

Inr Increased

Activated Partial Thromboplastin Time Prolonged

Hypoxia

Localized Edema

Lung Infection

Intra-Abdominal Hemorrhage

Flashing Lights

Chest Pain - Cardiac

Palpitations

Tinnitus

Gastroesophageal Reflux Disease

Malaise

Infusion Related Reaction

Allergic Reaction

Upper Respiratory Infection

Skin Infection

Hypoglycemia

Sinus Disorder

Confusion

Chest Wall Pain

Neck Pain

Syncope

Ear Pain

Peripheral Motor Neuropathy

Hyperhidrosis

Acute Kidney Injury

Infusion Site Extravasation

Febrile Neutropenia

Sinus Bradycardia

Myocardial Infarction

Purpura

Gastritis

Cataract

Vaginal Hemorrhage

Retinopathy

Floaters

Sepsis

Intracranial Hemorrhage

Ventricular Tachycardia

Hip Fracture

Gallbladder Pain

Pharyngitis

Dyspepsia

Rectal Hemorrhage

Oral Pain

Flatulence

Enterocolitis

Wound Infection

Anal Fistula

Salivary Gland Infection

Gum Infection

Upper Gastrointestinal Hemorrhage

Fecal Incontinence

Mucosal Infection

Conjunctivitis Infective

Oral Hemorrhage

Injection Site Reaction

Gastroparesis

Hepatobiliary Disorders - Other

Gait Disturbance

Pelvic Pain

Gallbladder Obstruction

Pulmonary Hypertension

Nail Infection

Nail Ridging

Suicidal Ideation

Acidosis

Muscle Weakness Lower Limb

Lymphedema

Pain Of Skin

Hypernatremia

Respiratory Failure

Palmar-Plantar Erythrodysesthesia Syndrome

Sneezing

Presyncope

Paresthesia

Akathisia

Hypercalcemia

Lethargy

Arthritis

Urinary Urgency

Facial Muscle Weakness

Ataxia

Movements Involuntary

Urinary Tract Obstruction

Erythema Multiforme

Superficial Thrombophlebitis

Pneumothorax

Watering Eyes

Laryngitis

Bladder Infection

Postoperative Hemorrhage

Fall

Bruising

Depressed Level Of Consciousness

Cognitive Disturbance

Pneumonitis

Sleep Apnea

Wheezing

Adrenal Insufficiency

Burn

Chronic Kidney Disease

Vaginal Pain

Agitation

Skin And Subcutaneous Tissue Disorders - Other

100%

80%

60%

40%

20%

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