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Monoclonal Antibodies

Elotuzumab for Myelofibrosis

Phase 2
Waitlist Available
Led By Prithviraj Bose
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bone marrow (BM) fibrosis grade 2 or 3 according to the European classification
Creatinine =< 2 x institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Must not have
Patients with known central nervous system (CNS) involvement
Other investigational agents within 4 half-lives prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a drug to see if it can help treat myelofibrosis, a disease which causes problems with blood cell production.

Who is the study for?
Adults with JAK2 V617F+ myelofibrosis needing treatment and at intermediate/high risk. They must have good performance status, specific blood counts, liver and kidney function levels, agree to use contraception, and not be candidates for JAK inhibitor therapy. Excluded are those recently on certain treatments or with allergies to similar drugs, CNS involvement, uncontrolled illnesses, pregnancy/lactation, HIV/HBV/HCV positivity or prior transplants.
What is being tested?
The trial is testing Elotuzumab's effectiveness in treating patients with JAK2-mutated myelofibrosis to control the disease and improve blood cell count and bone marrow function. It also includes questionnaire administration to gather patient-reported outcomes.
What are the potential side effects?
Elotuzumab may cause immune system-related side effects such as infusion reactions (symptoms during/after drug is given), fatigue, nausea, diarrhea; it can also affect blood cells leading to higher infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bone marrow fibrosis is moderate to severe.
Select...
My kidney function is within the required range.
Select...
I am mostly able to care for myself and remain up and about.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to my brain or spinal cord.
Select...
I haven't taken any experimental drugs recently.
Select...
I am positive for HIV, HBV, or HCV.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have had a stem cell transplant for myelofibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response (OR)
Secondary study objectives
Bone Marrow
Duration of response
Incidence of adverse events
+1 more
Other study objectives
Biomarker analysis

Side effects data

From 2022 Phase 3 trial • 170 Patients • NCT02726581
34%
Fatigue
31%
Upper respiratory tract infection
31%
Neutropenia
29%
Anaemia
24%
Pneumonia
24%
Diarrhoea
21%
Oedema peripheral
21%
Back pain
21%
Constipation
21%
Dyspnoea
17%
Nasopharyngitis
17%
Asthenia
17%
Cough
16%
Insomnia
16%
Nausea
16%
Thrombocytopenia
16%
Muscle spasms
14%
Decreased appetite
14%
Dizziness
14%
Hyperglycaemia
13%
Pyrexia
13%
Hypertension
11%
Rash
11%
Arthralgia
10%
Platelet count decreased
10%
White blood cell count decreased
10%
Headache
10%
Hypomagnesaemia
9%
Lymphocyte count decreased
9%
Vomiting
9%
Pain
9%
Neuropathy peripheral
9%
Malignant neoplasm progression
9%
Neutrophil count decreased
9%
Hypokalaemia
9%
Tremor
9%
Confusional state
9%
Respiratory tract infection
9%
Bone pain
7%
Bronchitis
7%
Urinary tract infection
7%
Abdominal pain
7%
Abdominal distension
7%
Dry mouth
6%
Cataract
6%
Paraesthesia
6%
Wheezing
6%
Chest pain
6%
Chills
6%
Non-cardiac chest pain
6%
Hypophosphataemia
6%
Muscular weakness
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Anxiety
6%
Chronic kidney disease
6%
Dysphonia
6%
Nasal congestion
6%
Pruritus
6%
Blood creatinine increased
4%
Acute kidney injury
4%
Hyperkalaemia
4%
Hyperuricaemia
4%
Febrile neutropenia
4%
Influenza
4%
Fall
4%
Hypercalcaemia
4%
Pain in extremity
4%
Epistaxis
4%
Sepsis
4%
Hypocalcaemia
3%
Pulmonary embolism
3%
Hypoaesthesia
3%
Leukopenia
3%
Humerus fracture
3%
Plasma cell myeloma
3%
Syncope
3%
Respiratory failure
3%
Sinusitis
3%
Alanine aminotransferase increased
3%
Productive cough
3%
Atrial fibrillation
3%
Septic shock
3%
Vision blurred
3%
Cardiac failure
3%
Aspartate aminotransferase increased
3%
Hyponatraemia
1%
Myocardial infarction
1%
Pulmonary sepsis
1%
Hand-foot-and-mouth disease
1%
Rhinovirus infection
1%
Skin laceration
1%
Cerebral thrombosis
1%
Renal failure
1%
Dehydration
1%
Peripheral sensory neuropathy
1%
Urinary retention
1%
Alopecia
1%
Cytomegalovirus viraemia
1%
Diverticulitis
1%
Erysipelas
1%
Escherichia urinary tract infection
1%
Gastroenteritis
1%
Pneumonia fungal
1%
Pneumonia legionella
1%
Atrioventricular block complete
1%
Cardiac arrest
1%
Cardiac failure acute
1%
Sinus node dysfunction
1%
Vertigo
1%
Condition aggravated
1%
Respiratory syncytial virus infection
1%
Hypersensitivity
1%
Bacteraemia
1%
Cellulitis
1%
Wound infection
1%
Femur fracture
1%
Lower limb fracture
1%
Lung cancer metastatic
1%
Encephalopathy
1%
Haemorrhage intracranial
1%
Renal impairment
1%
Acute respiratory failure
1%
Dyspnoea exertional
1%
Deep vein thrombosis
1%
Lymphopenia
1%
Pancytopenia
1%
Sinus bradycardia
1%
Hyperthyroidism
1%
Candida infection
1%
Neck pain
1%
Atelectasis
1%
Hypoxia
1%
Hypotension
1%
Infection
1%
Plasmacytoma
1%
Refractory cytopenia with unilineage dysplasia
1%
Hypovolaemic shock
1%
Impaired healing
1%
Post procedural complication
1%
Arthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Pd
Arm C: NE-Pd
Arm B: NE-Pd Crossover
Arm A: N-Pd

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (elotuzumab)Experimental Treatment2 Interventions
Patients receive elotuzumab IV over 1-4 hours on days 1, 8, 15, and 22 of cycles 1-2. Beginning in cycle 3, patients receive elotuzumab IV over 1-4 hours on day 1. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,230 Total Patients Enrolled
28 Trials studying Primary Myelofibrosis
999 Patients Enrolled for Primary Myelofibrosis
Prithviraj BosePrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
133 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
64 Patients Enrolled for Primary Myelofibrosis

Media Library

Elotuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04517851 — Phase 2
Primary Myelofibrosis Research Study Groups: Treatment (elotuzumab)
Primary Myelofibrosis Clinical Trial 2023: Elotuzumab Highlights & Side Effects. Trial Name: NCT04517851 — Phase 2
Elotuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04517851 — Phase 2
~3 spots leftby Dec 2025
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