Your session is about to expire
← Back to Search
Continued Elotuzumab Treatment for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless bms chooses to extend the study.
Awards & highlights
Study Summary
This trial is for people who have participated in a previous study on elotuzumab and who can't get the drug from other sources.
Who is the study for?
This trial is for adults who have benefited from previous elotuzumab studies for multiple myeloma and are currently on treatment. It's not open to those who stopped earlier trials for any reason or aren't seeing benefits from the past treatments.Check my eligibility
What is being tested?
The study continues providing elotuzumab and possibly other drugs like Dexamethasone, Bortezomib, Pomalidomide, Nivolumab, or Lenalidomide to participants of prior related trials where commercial supply isn't available.See study design
What are the potential side effects?
Possible side effects include immune system reactions, fatigue, nausea, infections risk increase, blood clots and nerve damage. Specific side effects depend on the combination of medications received.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking elotuzumab or other study drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless bms chooses to extend the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless bms chooses to extend the study.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
Secondary outcome measures
All Grade 5 adverse events (AEs) will be collected.
All adverse events (AEs) leading to discontinuation will be collected.
All adverse events (AEs) previously not reported will be collected.
+1 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%
Rhinovirus infection
1%
Renal failure
1%
Skin laceration
1%
Cerebral thrombosis
1%
Urinary retention
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: ElotuzumabExperimental Treatment6 Interventions
This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Elotuzumab
2016
Completed Phase 3
~800
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140
Nivolumab
2014
Completed Phase 3
~4750
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,447 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,853 Patients Enrolled for Multiple Myeloma
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,038 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,324 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were previously in a study with elotuzumab but had to stop for any reason.I am not healthy enough for the study treatment, as decided by the doctor.I am 18 years old or older.You did not get better from the treatment in a previous study.You have previously taken elotuzumab in another study and are still benefiting from it, as decided by the doctor.I am currently taking elotuzumab or other study drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Elotuzumab
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.
How many people are allowed to be a part of this test group?
"Unfortunately, this trial is no longer open for recruitment. However, it may be worth looking into the 825 other clinical trials presently underway for patients with multiple myeloma or the 1524 trials involving Elotuzumab."
Answered by AI
What is the FDA's official stance on Elotuzumab?
"Elotuzumab's safety is based on Phase 2 trial data, which only provides limited support for its efficacy. Consequently, it received a score of 2."
Answered by AI
What are some of the most popular maladies that Elotuzumab has been shown to help?
"While most commonly used as a treatment for ophthalmia, sympathetic, elotuzumab can also be taken to treat branch retinal vein occlusion and macular edema in patients that have undergone at least two rounds of systemic chemotherapy."
Answered by AI
Are there any other ongoing studies that include Elotuzumab?
"Elotuzumab was first studied 18 years ago at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. There have been a total of 1884 completed studies since then. Right now, there are 1524 clinical trials actively recruiting patients, with many of them based in Boston, Massachusetts."
Answered by AI
On how many different continents is this trial taking place?
"Currently, this clinical trial is seeking patients from a total of 18 different medical facilities. These locations include Boston, Bethlehem, and Saint Louis. There are also 15 other sites. To minimize travel requirements, it is best to select the clinic that is closest to your location."
Answered by AI
Are research subjects still being recruited for this trial?
"From what is listed on clinicaltrials.gov, it appears that this study is not presently recruiting patients for participation. This trial was originally posted on July 15th, 2016 and the most recent update was September 22nd, 2022. Although this specific trial isn't looking for participants at the moment, there are 2349 other trials that are currently doing so."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger