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Monoclonal Antibodies
Elotuzumab for Myelofibrosis
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response (OR)
Secondary outcome measures
Bone Marrow
Duration of response
Incidence of adverse events
+5 moreOther outcome measures
Biomarker analysis
JAK2V617F allele burden in the bone marrow or blood
Bone Marrow
+2 moreSide effects data
From 2022 Phase 3 trial • 170 Patients • NCT0272658134%
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%
Dizziness
14%
Decreased appetite
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%
Pain
9%
Vomiting
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%
Urinary tract infection
7%
Bronchitis
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%
Hyperuricaemia
4%
Hyperkalaemia
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%
Skin laceration
1%
Urinary retention
1%
Renal failure
1%
Rhinovirus infection
1%
Cerebral thrombosis
1%
Myocardial infarction
1%
Hand-foot-and-mouth disease
1%
Pulmonary sepsis
1%
Peripheral sensory neuropathy
1%
Dehydration
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
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
2,973 Previous Clinical Trials
1,789,331 Total Patients Enrolled
26 Trials studying Primary Myelofibrosis
897 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation to my spleen in the last 4 months.My cancer has spread to my brain or spinal cord.I haven't taken any experimental drugs recently.I am positive for HIV, HBV, or HCV.I have a type of blood cancer called myelofibrosis with a specific mutation and it's considered intermediate or high risk.My bone marrow fibrosis is moderate to severe.My kidney function is within the required range.You have had allergic reactions to similar drugs as elotuzumab in the past.I haven't taken specific cancer treatments or recovered from their side effects in the last 4 weeks.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your doctor has determined that you should not receive JAK inhibitor therapy.I am mostly able to care for myself and remain up and about.I have had a stem cell transplant for myelofibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (elotuzumab)
Awards:
This trial has 2 awards, including:- 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.
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.
What is the scope of this clinical experiment in terms of participant numbers?
"Yes, clinicaltrials.gov evidences that this research is actively recruiting volunteers for a trial which was first made public on February 10th 2021 and most recently updated in November 11th 2022. The study requires 15 participants from 1 medical centre."
Answered by AI
Is there capacity for more volunteers at this trial?
"According to the entry on clinicaltrials.gov, this medical trial is open to participants and has seen recent updates since its initiation back in February 2021. The most recent changes were posted on November 2022."
Answered by AI
Has Elotuzumab been tested in other laboratory settings?
"Currently, there are 23 clinical trials being conducted with elotuzumab. Of these studies, 3 have reached phase III and 857 sites around the world are involved in their execution. The majority of locations for this research are located within Houston, Texas."
Answered by AI
Could you provide an overview of Elotuzumab's safety profile?
"Elotuzumab's safety rating on a scale from 1-3 is 2 as this phase 2 trial has generated data supporting its security, yet efficacy remains unproven."
Answered by AI
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