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Continued Elotuzumab Treatment for Multiple Myeloma
Aomori-shi, Japan
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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
See full description
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.
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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
Side effects data
From 2022 Phase 3 trial • 170 Patients • NCT0272658134%
Fatigue
31%
Neutropenia
31%
Upper respiratory tract infection
29%
Anaemia
24%
Pneumonia
24%
Diarrhoea
21%
Oedema peripheral
21%
Back pain
21%
Dyspnoea
21%
Constipation
17%
Asthenia
17%
Nasopharyngitis
17%
Cough
16%
Thrombocytopenia
16%
Nausea
16%
Insomnia
16%
Muscle spasms
14%
Dizziness
14%
Hyperglycaemia
14%
Decreased appetite
13%
Pyrexia
13%
Hypertension
11%
Rash
11%
Arthralgia
10%
Platelet count decreased
10%
Headache
10%
White blood cell count decreased
10%
Hypomagnesaemia
9%
Pain
9%
Neutrophil count decreased
9%
Neuropathy peripheral
9%
Confusional state
9%
Malignant neoplasm progression
9%
Respiratory tract infection
9%
Vomiting
9%
Lymphocyte count decreased
9%
Bone pain
9%
Hypokalaemia
9%
Tremor
7%
Abdominal distension
7%
Abdominal pain
7%
Bronchitis
7%
Dry mouth
7%
Urinary tract infection
6%
Non-cardiac chest pain
6%
Blood creatinine increased
6%
Chronic kidney disease
6%
Pruritus
6%
Chills
6%
Muscular weakness
6%
Dysphonia
6%
Nasal congestion
6%
Wheezing
6%
Cataract
6%
Chest pain
6%
Hypophosphataemia
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Paraesthesia
6%
Anxiety
4%
Sepsis
4%
Acute kidney injury
4%
Influenza
4%
Fall
4%
Hyperuricaemia
4%
Pain in extremity
4%
Febrile neutropenia
4%
Epistaxis
4%
Hypercalcaemia
4%
Hyperkalaemia
4%
Hypocalcaemia
3%
Septic shock
3%
Humerus fracture
3%
Plasma cell myeloma
3%
Respiratory failure
3%
Leukopenia
3%
Sinusitis
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Hypoaesthesia
3%
Atrial fibrillation
3%
Cardiac failure
3%
Productive cough
3%
Syncope
3%
Pulmonary embolism
3%
Vision blurred
3%
Hyponatraemia
1%
Condition aggravated
1%
Hypersensitivity
1%
Sinus node dysfunction
1%
Vertigo
1%
Bacteraemia
1%
Erysipelas
1%
Escherichia urinary tract infection
1%
Infection
1%
Pneumonia fungal
1%
Pulmonary sepsis
1%
Respiratory syncytial virus infection
1%
Rhinovirus infection
1%
Wound infection
1%
Femur fracture
1%
Lower limb fracture
1%
Arthritis
1%
Plasmacytoma
1%
Refractory cytopenia with unilineage dysplasia
1%
Cerebral thrombosis
1%
Encephalopathy
1%
Deep vein thrombosis
1%
Hypovolaemic shock
1%
Lymphopenia
1%
Pancytopenia
1%
Sinus bradycardia
1%
Hyperthyroidism
1%
Candida infection
1%
Dehydration
1%
Neck pain
1%
Peripheral sensory neuropathy
1%
Urinary retention
1%
Myocardial infarction
1%
Lung cancer metastatic
1%
Cytomegalovirus viraemia
1%
Pneumonia legionella
1%
Atelectasis
1%
Hypoxia
1%
Cardiac failure acute
1%
Cardiac arrest
1%
Impaired healing
1%
Diverticulitis
1%
Cellulitis
1%
Gastroenteritis
1%
Hand-foot-and-mouth disease
1%
Atrioventricular block complete
1%
Alopecia
1%
Skin laceration
1%
Post procedural complication
1%
Haemorrhage intracranial
1%
Renal failure
1%
Renal impairment
1%
Acute respiratory failure
1%
Dyspnoea exertional
1%
Hypotension
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
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: 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
~1060
Elotuzumab
2016
Completed Phase 3
~950
Dexamethasone
2007
Completed Phase 4
~2650
Bortezomib
2005
Completed Phase 3
~1410
Nivolumab
2014
Completed Phase 3
~3880
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Closest Location:Washington University School Of Medicine· Saint Louis, MO
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,730 Previous Clinical Trials
4,129,036 Total Patients Enrolled
93 Trials studying Multiple Myeloma
24,306 Patients Enrolled for Multiple Myeloma
AbbVieIndustry Sponsor
1,071 Previous Clinical Trials
533,151 Total Patients Enrolled
34 Trials studying Multiple Myeloma
4,873 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.