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Belantamab Mafodotin + Lenalidomide for Multiple Myeloma
Phase 2
Recruiting
Led By Qaiser Bashir
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Woman of nonchildbearing potential as defined by age or medical reasons
Male participant agrees to contraceptive use or abstinence
Must not have
Presence of active renal condition
Major surgery ≤ 4 weeks before initiating study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial is testing a new treatment for multiple myeloma that may help patients achieve remission.
Who is the study for?
This trial is for adults aged 18-75 with newly diagnosed multiple myeloma who have had a stem cell transplant. They must be partially responsive to treatment, in good physical condition, and able to follow strict birth control guidelines. People with progressive disease, certain other myeloma types, eye diseases, recent major surgery or known allergies to the drugs can't join.Check my eligibility
What is being tested?
The study tests if adding Belantamab Mafodotin to Lenalidomide after a stem cell transplant helps patients achieve better outcomes by turning more MRD-positive cases into MRD-negative ones.See study design
What are the potential side effects?
Possible side effects include eye problems like blurry vision or dry eyes (especially since contact lens use is restricted), blood disorders, fatigue, digestive issues and increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot become pregnant due to my age or medical reasons.
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I agree to use contraception or practice abstinence.
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I am able to care for myself but cannot do any heavy physical work.
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My cancer shows signs of responding to treatment or is undetectable.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active kidney condition.
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I have not had major surgery in the last 4 weeks.
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I am currently experiencing bleeding from an internal organ or mucosa.
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I am currently being treated for an infection.
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I do not have any serious or unstable health or mental conditions.
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I have been diagnosed with plasma cell leukemia.
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All my side effects from previous treatments are mild, except for hair loss.
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I have a current eye surface condition.
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My multiple myeloma does not produce detectable levels of M protein.
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My cancer has worsened before starting maintenance therapy.
Select...
I have been diagnosed with smoldering multiple myeloma.
Select...
I am HIV positive.
Select...
My liver condition is stable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.
Side effects data
From 2024 Phase 1 & 2 trial • 153 Patients • NCT0354428192%
Keratopathy
54%
Vision blurred
46%
Diarrhoea
38%
Platelet count decreased
31%
Nausea
31%
Neutrophil count decreased
31%
Fatigue
31%
Anaemia
31%
Visual acuity reduced
23%
Constipation
23%
Arthralgia
23%
Back pain
23%
Neutropenia
15%
Infusion related reaction
15%
Visual acuity tests abnormal
15%
Muscle spasms
15%
Influenza like illness
15%
Rhinovirus infection
15%
Foreign body sensation in eyes
15%
Thrombocytopenia
15%
Agitation
15%
Atrial fibrillation
15%
COVID-19
15%
Hyperglycaemia
15%
Osteonecrosis of jaw
15%
Skin laceration
15%
Pain in extremity
15%
Upper respiratory tract infection
8%
Asthenia
8%
Campylobacter gastroenteritis
8%
Incarcerated inguinal hernia
8%
Anal haemorrhage
8%
Peripheral sensory neuropathy
8%
Erectile dysfunction
8%
Sinus bradycardia
8%
Pneumothorax
8%
Lymphopenia
8%
Dry mouth
8%
Device related infection
8%
Ejection fraction decreased
8%
Weight decreased
8%
Cough
8%
Weight increased
8%
Tinnitus
8%
Campylobacter infection
8%
Respiratory tract infection
8%
Contusion
8%
Blood creatinine increased
8%
Arthritis
8%
Migraine
8%
Sensory loss
8%
Diplopia
8%
Abdominal distension
8%
Dyspepsia
8%
Gastrooesophageal reflux disease
8%
Irritable bowel syndrome
8%
Urinary tract pain
8%
Conjunctival haemorrhage
8%
Gingivitis
8%
Pneumocystis jirovecii pneumonia
8%
Haemorrhoids
8%
Musculoskeletal chest pain
8%
Cataract
8%
Hypokalaemia
8%
Insomnia
8%
Lethargy
8%
Memory impairment
8%
Photophobia
8%
Rectal haemorrhage
8%
Eye pain
8%
Aspartate aminotransferase increased
8%
Rash
8%
Epistaxis
8%
Actinic keratosis
8%
Neuroendocrine tumour
8%
Skin cancer
8%
Limb injury
8%
Decreased appetite
8%
Abdominal discomfort
8%
Flatulence
8%
Hyperuricaemia
8%
Oropharyngeal pain
8%
Anxiety
8%
Atrial flutter
8%
Palpitations
8%
Abdominal pain upper
8%
Gingival pain
8%
Abdominal pain
8%
Liver function test abnormal
8%
Oedema peripheral
8%
Lumbar spinal stenosis
8%
Electrocardiogram QT prolonged
8%
Myalgia
8%
Neck pain
8%
Hiccups
8%
Rhinorrhoea
8%
Periodontitis
8%
Purpura
8%
Hypotension
8%
Cerebrovascular accident
8%
Anal incontinence
8%
Urticaria
8%
Skin abrasion
8%
Petechiae
8%
Vomiting
8%
Eye infection
8%
Pneumonia
8%
Bronchitis
8%
Bone pain
8%
Chronic kidney disease
8%
Proteinuria
8%
Hypertension
8%
Skin ulcer
8%
Inguinal hernia
8%
Gastroenteritis
8%
Blood creatine phosphokinase increased
8%
Nasopharyngitis
8%
Skin lesion
8%
Gastroenteritis norovirus
8%
Troponin T increased
8%
Alanine aminotransferase increased
8%
Dyspnoea
8%
Pyrexia
8%
Erythema
8%
COVID-19 pneumonia
8%
Lower respiratory tract infection
8%
Staphylococcus test positive
8%
Hypercalcaemia
8%
Paraesthesia
8%
Confusional state
8%
Pruritus
8%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 3.4 mg/kg SINGLE + 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 1.9 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Trial Design
2Treatment groups
Experimental Treatment
Group I: LenalidomideExperimental Treatment1 Intervention
lenalidomide by mouth every day of each cycle
Group II: Belantamab mafodotinExperimental Treatment1 Intervention
belantamab mafodotin by vein over about 30 minutes on Day 1 of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 2
~160
Lenalidomide
2005
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,185 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,718 Patients Enrolled for Multiple Myeloma
Qaiser BashirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Multiple Myeloma
62 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot become pregnant due to my age or medical reasons.I agree to use contraception or practice abstinence.I have an active kidney condition.You have tested positive for hepatitis C unless you meet specific criteria.I have not had major surgery in the last 4 weeks.I am currently experiencing bleeding from an internal organ or mucosa.I am currently being treated for an infection.I have Hepatitis B but meet the specific criteria for treatment.I have no other cancers, or they've been stable for 2 years.I haven't taken any new or approved myeloma drugs recently.I do not have any serious or unstable health or mental conditions.I have been diagnosed with plasma cell leukemia.I have been treated with a monoclonal antibody recently.My organs are working well.I am able to care for myself but cannot do any heavy physical work.All my side effects from previous treatments are mild, except for hair loss.I recently had my first stem cell transplant for multiple myeloma.My cancer shows signs of responding to treatment or is undetectable.I will not donate sperm during and for 4 weeks after my last dose of lenalidomide.I have a current eye surface condition.My multiple myeloma does not produce detectable levels of M protein.My cancer has worsened before starting maintenance therapy.I have been diagnosed with smoldering multiple myeloma.I am HIV positive.I am at risk for heart disease.I am between 18 and 75 years old.My liver condition is stable.I agree not to donate blood while on lenalidomide and for 28 days after.
Research Study Groups:
This trial has the following groups:- Group 1: Belantamab mafodotin
- Group 2: Lenalidomide
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.
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