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Monoclonal Antibodies

Elotuzumab, 20 mg/kg 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose to date of last dose plus 60 days (assessed up to august 2017, approximately 59 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56\^dim cells (a marker for the health of the body's immune system)

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to date of progression or objective response (assessed up to august 2017, approximately 59 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to date of progression or objective response (assessed up to august 2017, approximately 59 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
Secondary study objectives
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate
+2 more

Side effects data

From 2021 Phase 3 trial • 748 Patients • NCT01335399
51%
Fatigue
49%
Oedema peripheral
49%
Diarrhoea
43%
Anaemia
39%
Constipation
37%
Back pain
33%
Arthralgia
32%
Neutropenia
29%
Nausea
29%
Cough
26%
Insomnia
25%
Hypokalaemia
25%
Dyspnoea
23%
Decreased appetite
23%
Rash
23%
Upper respiratory tract infection
22%
Muscle spasms
21%
Pain in extremity
21%
Pyrexia
20%
Asthenia
20%
Hypocalcaemia
19%
Blood creatinine increased
19%
Thrombocytopenia
19%
Hyperglycaemia
18%
Weight decreased
18%
Dizziness
17%
Nasopharyngitis
16%
Peripheral sensory neuropathy
15%
Cataract
15%
Bone pain
15%
Urinary tract infection
15%
Tremor
14%
Muscular weakness
14%
Abdominal pain
14%
Bronchitis
14%
Contusion
13%
Musculoskeletal chest pain
13%
Pneumonia
13%
Vomiting
13%
Neuropathy peripheral
13%
Headache
12%
Hypotension
12%
Pruritus
12%
Hypertension
12%
Paraesthesia
10%
Neck pain
10%
Leukopenia
9%
Chest pain
9%
Respiratory tract infection
9%
Fall
9%
Dyspepsia
9%
Confusional state
8%
Neutrophil count decreased
8%
Abdominal pain upper
8%
Influenza like illness
8%
Vision blurred
8%
Anxiety
8%
Depression
7%
Oropharyngeal pain
7%
Hyperhidrosis
7%
Atrial fibrillation
7%
Cellulitis
7%
Hypoaesthesia
7%
Dysphonia
7%
Deep vein thrombosis
7%
Alanine aminotransferase increased
7%
Taste disorder
7%
Dry mouth
6%
Peripheral swelling
6%
Hypomagnesaemia
6%
Musculoskeletal pain
6%
Aspartate aminotransferase increased
6%
Dehydration
6%
Hypoalbuminaemia
6%
Dry skin
6%
Erythema
6%
Spinal pain
6%
Skin laceration
5%
Acute kidney injury
5%
Joint swelling
5%
Epistaxis
5%
Platelet count decreased
5%
Myalgia
5%
Dyspnoea exertional
5%
Skin lesion
5%
Non-cardiac chest pain
5%
Oedema
5%
Pain
5%
Cystitis
5%
Agitation
5%
Productive cough
5%
Flushing
5%
Sinusitis
5%
Haemorrhoids
5%
Glomerular filtration rate decreased
5%
Hyponatraemia
5%
Syncope
5%
Mood altered
5%
Dysuria
5%
Pollakiuria
5%
Herpes zoster
5%
Influenza
4%
Hypophosphataemia
4%
Skin abrasion
4%
Memory impairment
4%
Night sweats
4%
Toothache
4%
Dysgeusia
4%
Pulmonary embolism
3%
Basal cell carcinoma
3%
Oral herpes
3%
Pain in jaw
2%
Chills
2%
Chronic obstructive pulmonary disease
2%
Lower respiratory tract infection
2%
Sepsis
2%
Septic shock
2%
Femur fracture
2%
Squamous cell carcinoma
2%
Renal failure
2%
Mucosal inflammation
2%
Cardiac arrest
2%
Cardiac failure
2%
Squamous cell carcinoma of skin
2%
Cerebrovascular accident
1%
Intestinal perforation
1%
Urosepsis
1%
Femoral neck fracture
1%
Cerebral infarction
1%
Acute coronary syndrome
1%
Pleural effusion
1%
Haematuria
1%
Febrile neutropenia
1%
Arrhythmia
1%
Atrial flutter
1%
Atrial tachycardia
1%
Gastroenteritis
1%
Left ventricular dysfunction
1%
Myocardial infarction
1%
Ileus
1%
Interstitial lung disease
1%
Cardiac failure congestive
1%
Inguinal hernia
1%
Intestinal obstruction
1%
Pancreatitis
1%
Death
1%
Disease progression
1%
General physical health deterioration
1%
Fibula fracture
1%
Hip fracture
1%
Pelvic fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Spinal fracture
1%
Tibia fracture
1%
Traumatic fracture
1%
Transaminases increased
1%
Acute lymphocytic leukaemia
1%
Lung adenocarcinoma
1%
Malignant melanoma in situ
1%
Plasma cell myeloma
1%
Cerebral haemorrhage
1%
Cerebral ischaemia
1%
Renal impairment
1%
Hypoxia
1%
Rectal haemorrhage
1%
Subdural haematoma
1%
Osteonecrosis of jaw
1%
Bowen's disease
1%
Transient ischaemic attack
1%
Exfoliative rash
1%
Nephrolithiasis
1%
Aortic aneurysm
1%
Pyelonephritis
1%
Diverticulitis
1%
Escherichia bacteraemia
1%
Pneumonitis
1%
Pulmonary oedema
1%
Respiratory failure
1%
Electrolyte imbalance
1%
Failure to thrive
1%
Hypercalcaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ld Cohort
E-Ld Cohort

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

2Treatment groups
Experimental Treatment
Group I: Elotuzumab, 20 mg/kgExperimental Treatment1 Intervention
Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.
Group II: Elotuzumab, 10 mg/kgExperimental Treatment1 Intervention
Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.
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?

AbbVieIndustry Sponsor
1,023 Previous Clinical Trials
520,248 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,024 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,528 Total Patients Enrolled
90 Trials studying Multiple Myeloma
22,392 Patients Enrolled for Multiple Myeloma
~3 spots leftby Nov 2025
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