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Monoclonal Antibodies
Belantamab + Elotuzumab for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy as defined by IMWG criteria
Participant must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up followed for progression free survival until progression up to 2 years
Awards & highlights
Study Summary
This trial is testing if two drugs used to treat cancer are more effective when used together.
Who is the study for?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to at least three prior treatments. They must have decent organ function, not be pregnant, and agree to use contraception. People can't join if they've had recent major surgery, active infections needing IV treatment, certain eye diseases, unstable heart conditions, or used other investigational drugs recently.Check my eligibility
What is being tested?
The study tests the combination of two approved drugs for multiple myeloma—Belantamab Mafodotin and Elotuzumab—to see if they work better together. Participants will receive both medications under controlled conditions to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include vision issues due to Belantamab Mafodotin (participants cannot wear contact lenses), as well as general risks like infection susceptibility increase, allergic reactions related to either drug's components, bleeding complications or liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has not responded to at least 3 previous treatments.
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I am 18 years old or older.
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My blood counts and organ functions are within the required ranges.
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I am using or willing to use contraception as required.
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All my side effects from previous treatments are mild, except for hair loss.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ followed for progression free survival until progression up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~followed for progression free survival until progression up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of elotuzumab in combination with belantamab mafodotin in subjects
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Preliminary evaluation of clinical efficacy/response rate
To evaluate minimal residual disease (MRD) by multi-parameter flow cytometry and by next-generation sequencing (NGS)
To evaluate overall survival (OS)
+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%
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: Belantamab Mafodotin and Elotuzumab ArmExperimental Treatment2 Interventions
Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days.
Belantamab mafodotin will be administered via IV infusion. There will be 2 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested. .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
2016
Completed Phase 3
~800
Belantamab mafodotin
2019
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,189 Total Patients Enrolled
6 Trials studying Multiple Myeloma
210 Patients Enrolled for Multiple Myeloma
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,664 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,409 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with iMID and proteasome inhibitors before.My multiple myeloma has not responded to at least 3 previous treatments.I have not undergone plasmapheresis in the last 7 days.I do not have any serious eye surface diseases.I have not had major surgery in the last 4 weeks.I have no other cancers, or any second cancer has been stable for 2+ years.I am 18 years old or older.My blood counts and organ functions are within the required ranges.I am not allergic to belantamab mafodotin or similar drugs.I am using or willing to use contraception as required.I do not have any heart-related health risks.All my side effects from previous treatments are mild, except for hair loss.I haven't had monoclonal antibody treatment in the last 30 days.I do not have HIV.I do not have any current bleeding from internal organs or mucous membranes.My liver is currently stable, without any severe disease.I do not have an active kidney condition.I haven't taken any experimental drugs or standard myeloma treatments in the last 14 days.I do not have hepatitis C.I do not have an infection that needs IV antibiotics.I do not have hepatitis B.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Belantamab Mafodotin and Elotuzumab Arm
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.
What outcomes is this investigation seeking to attain?
"According to GlaxoSmithKline's report, the primary outcome for this trial will be measured over a 28 day period and is evaluating Dose-Limiting Toxicities (DLTs). In addition, secondary measurements include Progression Free Survival (PFS) which employs an IMWG Response Criteria; Overall Survival (OS), following patients until study termination or death from any cause; and Minimal Residual Disease (MRD) evaluated through multi-parameter flow cytometry and Next Generation Sequencing of bone marrow biopsies."
Answered by AI
Are there currently any opportunities for patients to participate in this experiment?
"Per information on clinicaltrials.gov, patient recruitment for this medical trial is ongoing. This study was initially posted to the public domain on February 21st 2022 and has been updated as recently at August 15th 2022."
Answered by AI
In what medical contexts is Elotuzumab commonly prescribed?
"Elotuzumab has been demonstrated to be an effective immunomodulatory agent for multiple myeloma that is refractory to proteasome inhibitors."
Answered by AI
Are there other reports of Elotuzumab being tested in clinical trials?
"Presently, 54 trials are being conducted for Elotuzumab with 7 in the last phase of testing. Although much of the work is occuring out of Milwaukee, Wisconsin, there are 1,705 active sites across the globe running studies on this therapy."
Answered by AI
How many individuals are currently taking part in this research endeavor?
"Confirmed. According to clinicaltrials.gov, this research study initiated on February 21st 2022 and has been collecting new data as recently as August 15th 2022 is actively seeking applicants. For the project, 24 subjects at one site are required."
Answered by AI
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