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Monoclonal Antibodies

Belantamab Mafodotin + SoC for Multiple Myeloma (DREAMM 9 Trial)

Phase 1

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Capable of giving signed informed consent

Adequate organ system functions as defined by specific laboratory assessments

Must not have

Participant is eligible for high dose chemotherapy with ASCT, as determined by a frailty score of 0 as assessed by the IMWG frailty index

Known human immunodeficiency virus (HIV) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to an average of 54 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new drug, belantamab mafodotin, in combination with other drugs, for people with newly diagnosed multiple myeloma.

Who is the study for?

Adults over 18 with newly diagnosed multiple myeloma needing treatment, not eligible for stem cell transplant due to other health issues. They must have measurable disease, be able to perform daily activities (ECOG 0-2), and have proper organ function. Participants must use contraception and give informed consent. Excluded are those with active bleeding, liver disease, heart risks, infections requiring treatment, certain allergies or previous cancers (with exceptions), recent major surgery or therapy for multiple myeloma.

What is being tested?

The trial tests Belantamab Mafodotin combined with standard drugs Bortezomib, Lenalidomide & Dexamethasone in adults with new multiple myeloma. The study will find the safest dose of Belantamab Mafodotin when given every 3-12 weeks alongside a regimen of the other drugs on specific cycles up to cycle 8 and then less frequently.

What are the potential side effects?

Potential side effects include eye problems like blurry vision or dry eyes (corneal issues), blood disorders such as low platelet counts or anemia, fatigue, nausea and vomiting from chemotherapy drugs; risk of infection may increase due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am able to understand and sign the consent form.

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My organ functions are within normal ranges according to recent tests.

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I have been diagnosed with multiple myeloma and need treatment.

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I am able to get out of my bed or chair and move around.

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I am over 18 years old.

Exclusion Criteria

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

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I am considered fit for high dose chemotherapy with stem cell transplant.

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I am HIV positive.

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I cannot tolerate blood clot prevention medication.

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I have not undergone plasmapheresis within the last week.

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I am currently being treated for an infection.

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My multiple myeloma has affected my brain or spinal cord.

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I have ongoing bleeding inside my body that treatments haven't stopped.

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I have AL amyloidosis, POEMS syndrome, or active plasma cell leukemia.

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I have not had major surgery in the last 4 weeks.

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

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I have moderate to severe nerve pain or damage.

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I have been diagnosed with smoldering multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to an average of 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to an average of 54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to an average of 54 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

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Number of participants with dose-limiting toxicities (DLTs)

Secondary study objectives

AUC of cys-mcMMAF

Area under the concentration time curve (AUC) of belantamab mafodotin

Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd

+9 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

10Treatment groups

Experimental Treatment

Group I: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/RdExperimental Treatment4 Interventions

Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Group II: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/RdExperimental Treatment4 Interventions

Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Group III: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/RdExperimental Treatment4 Interventions

Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Group IV: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions

Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Group V: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions

Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Group VI: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions

Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Group VII: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions

Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Group VIII: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions

Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.

Group IX: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions

Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.

Group X: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions

Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 3

~1410

Lenalidomide

2005

Completed Phase 3

~2240