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Antibody-drug Conjugate

Belantamab Mafodotin Combinations for Multiple Myeloma (DREAMM 6 Trial)

East Setauket, NY

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy

Have undergone stem cell transplant (SCT), or are considered transplant ineligible

Must not have

Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension

Current corneal disease except for mild punctute keratopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new drug, belantamab mafodotin, when used in combination with either Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone, in patients with RRMM who have relapsed or are refractory to at least one line of approved therapy.

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Who is the study for?

Adults with relapsed/refractory Multiple Myeloma who've had at least one prior treatment can join this trial. They must have measurable disease, be in good physical condition (ECOG 0-1 for Arm A, ECOG 0-2 for Arm B), and not have severe organ damage or active infections. Women of childbearing potential must use effective contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of GSK2857916 combined with Lenalidomide plus Dexamethasone (Arm A) or Bortezomib plus Dexamethasone (Arm B). It has two parts: dose escalation to find a safe dosage and then further evaluation of that dosage's clinical activity.See study design

What are the potential side effects?

Possible side effects include eye problems, infusion reactions, blood disorders, fatigue, infection risk increase, and organ inflammation. Specific side effects may depend on whether patients are in Arm A or Arm B due to different combination therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has worsened despite having at least one treatment.

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I have had a stem cell transplant or am not eligible for one.

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I have been diagnosed with Multiple Myeloma.

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I am not pregnant, can test before treatment, and will use birth control during and after the study.

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Exclusion Criteria

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

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I have heart problems like uncontrolled high blood pressure or recent heart attacks.

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I have a mild eye condition but no serious corneal disease.

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I haven't taken any experimental drugs recently.

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I haven't had any myeloma treatment or plasmapheresis in the last 2 weeks.

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I am currently experiencing bleeding from an internal organ or mucosa.

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I have a mild eye condition but no serious corneal disease.

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I am currently being treated for an infection.

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I am HIV positive.

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I can tolerate blood clot prevention medication and have not stopped lenalidomide due to side effects.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4.5 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

Change From Baseline in Urine Potential of Hydrogen (pH)

Change From Baseline in Urine Specific Gravity

Change From Baseline in Vital Signs : Pulse Rate

+12 more

Secondary study objectives

AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A

AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B

AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B

+66 more

Side effects data

From 2024 Phase 1 & 2 trial • 153 Patients • NCT03544281

75%

Keratopathy

42%

Visual acuity reduced

42%

Diarrhoea

42%

Insomnia

33%

Dizziness

33%

Urinary tract infection

33%

Neutrophil count decreased

25%

COVID-19

25%

Platelet count decreased

25%

Cough

17%

Upper respiratory tract infection

17%

Pneumonia

17%

Atrial fibrillation

17%

Anaemia

17%

Vertigo

17%

Cataract nuclear

17%

Foreign body sensation in eyes

17%

Abdominal pain

17%

Constipation

17%

Nausea

17%

Oedema peripheral

17%

Infusion related reaction

17%

Gamma-glutamyltransferase increased

17%

Headache

17%

Back pain

17%

Muscle spasms

17%

Muscular weakness

17%

Pain in extremity

17%

Anxiety

17%

Rash

Inguinal hernia

Hypertension

Cellulitis

Pseudomonas infection

Septic shock

Acute myocardial infarction

Cardiac failure congestive

Colitis

Pyrexia

Tricuspid valve incompetence

Lymphopenia

Thrombocytopenia

Cardiac failure

Mitral valve incompetence

Asthenopia

Blepharitis

Blepharospasm

Cataract

Cataract cortical

Dry eye

Eye irritation

Eye pain

Squamous cell carcinoma of skin

Meibomian gland dysfunction

Gastrooesophageal reflux disease

Haemorrhoids

Balance disorder

Paraesthesia oral

Asthenia

Feeling abnormal

Oedema

Hypertransaminasaemia

Gastroenteritis

Nail infection

Nasopharyngitis

Oral candidiasis

Respiratory tract infection

Viral infection

Chemical burns of eye

Contusion

Blood alkaline phosphatase increased

Weight decreased

Hyperglycaemia

Hypertriglyceridaemia

Hypocalcaemia

Hypokalaemia

Hypomagnesaemia

Hypophosphataemia

Bone pain

Bursitis

Myalgia

Lethargy

Paraesthesia

Peripheral sensory neuropathy

Restless legs syndrome

Tremor

Delirium

Acute kidney injury

Urinary incontinence

Vulvovaginal pruritus

Dyspnoea

Dyspnoea exertional

Epistaxis

Haemoptysis

Oropharyngeal discomfort

Blister

Cold urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex

Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Awards & Highlights

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: Arm B: Belantamab mafodotin+bortezomib+dexamethasoneExperimental Treatment3 Interventions

Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \& so on). Bortezomib will be administered at 1.3 mg/m\^2 SC/IV on Days 1,4,8, \& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \& 12 of every 21-day cycle.

Group II: Arm A: Belantamab mafodotin+lenalidomide +dexamethasoneExperimental Treatment3 Interventions

Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \& 22 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Dexamethasone

2007

Completed Phase 4

~2650