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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

Must not have

Participant must not have current corneal epithelial disease except mild changes in corneal epithelium

Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up followed for progression free survival until progression up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious eye surface diseases.

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I am not allergic to belantamab mafodotin or similar drugs.

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I do not have any heart-related health risks.

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I haven't had monoclonal antibody treatment in the last 30 days.

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I do not have HIV.

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I do not have any current bleeding from internal organs or mucous membranes.

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My liver is currently stable, without any severe disease.

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I do not have an active kidney condition.

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I do not have an infection that needs IV antibiotics.

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I do not have hepatitis B.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and followed for progression free survival until progression up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose of elotuzumab in combination with belantamab mafodotin in subjects

Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)

Secondary study objectives

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 more

Side effects data

From 2022 Phase 3 trial • 170 Patients • NCT02726581

34%

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%

Decreased appetite

14%

Dizziness

14%

Hyperglycaemia

13%

Pyrexia

13%

Hypertension

11%

Rash

11%

Arthralgia

10%

Platelet count decreased

10%

White blood cell count decreased

10%

Headache

10%

Hypomagnesaemia

Lymphocyte count decreased

Vomiting

Pain

Neuropathy peripheral

Malignant neoplasm progression

Neutrophil count decreased

Hypokalaemia

Tremor

Confusional state

Respiratory tract infection

Bone pain

Bronchitis

Urinary tract infection

Abdominal pain

Abdominal distension

Dry mouth

Cataract

Paraesthesia

Wheezing

Chest pain

Chills

Non-cardiac chest pain

Hypophosphataemia

Muscular weakness

Musculoskeletal chest pain

Myalgia

Anxiety

Chronic kidney disease

Dysphonia

Nasal congestion

Pruritus

Blood creatinine increased

Acute kidney injury

Hyperkalaemia

Hyperuricaemia

Febrile neutropenia

Influenza

Fall

Hypercalcaemia

Pain in extremity

Epistaxis

Sepsis

Hypocalcaemia

Pulmonary embolism

Hypoaesthesia

Leukopenia

Humerus fracture

Plasma cell myeloma

Syncope

Respiratory failure

Sinusitis

Alanine aminotransferase increased

Productive cough

Atrial fibrillation

Septic shock

Vision blurred

Cardiac failure

Aspartate aminotransferase increased

Hyponatraemia

Myocardial infarction

Pulmonary sepsis

Hand-foot-and-mouth disease

Rhinovirus infection

Skin laceration

Cerebral thrombosis

Renal failure

Dehydration

Peripheral sensory neuropathy

Urinary retention

Alopecia

Cytomegalovirus viraemia

Diverticulitis

Erysipelas

Escherichia urinary tract infection

Gastroenteritis

Pneumonia fungal

Pneumonia legionella

Atrioventricular block complete

Cardiac arrest

Cardiac failure acute

Sinus node dysfunction

Vertigo

Condition aggravated

Respiratory syncytial virus infection

Hypersensitivity

Bacteraemia

Cellulitis

Wound infection

Femur fracture

Lower limb fracture

Lung cancer metastatic

Encephalopathy

Haemorrhage intracranial

Renal impairment

Acute respiratory failure

Dyspnoea exertional

Deep vein thrombosis

Lymphopenia

Pancytopenia

Sinus bradycardia

Hyperthyroidism

Candida infection

Neck pain

Atelectasis

Hypoxia

Hypotension

Infection

Plasmacytoma

Refractory cytopenia with unilineage dysplasia

Hypovolaemic shock

Impaired healing

Post procedural complication

Arthritis

100%

80%

60%

40%

20%

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: 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 3 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, further dose reduction to 1.4mg/kg every 8 weeks will be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elotuzumab

2016

Completed Phase 3

~950

Belantamab mafodotin

2022

Completed Phase 2

~240