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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.
Select...
I agree to use contraception or practice abstinence.
Select...
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.
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 2022 Phase 1 trial • 6 Patients • NCT0417782367%
Blood lactate dehydrogenase increased
67%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Hyponatraemia
50%
Hypocalcaemia
50%
White blood cell count decreased
50%
Aspartate aminotransferase increased
50%
Neutrophil count decreased
50%
Hyperphosphataemia
50%
Pyrexia
33%
Alanine aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Hypercalcaemia
33%
Hyperuricaemia
33%
Hypokalaemia
33%
Hypomagnesaemia
33%
Punctate keratitis
33%
Vision blurred
17%
Hyperglycaemia
17%
Myelosuppression
17%
Liver injury
17%
Adenosine deaminase increased
17%
Alpha hydroxybutyrate dehydrogenase increased
17%
Glycocholic acid increased
17%
Protein total decreased
17%
Crystal urine present
17%
Gamma-glutamyltransferase increased
17%
Leucine aminopeptidase increased
17%
Lymphocyte count increased
17%
Prealbumin decreased
17%
Total bile acids increased
17%
Urinary occult blood
17%
Visual impairment
17%
Leukocytosis
17%
Thrombocytopenia
17%
Mouth ulceration
17%
Lung disorder
17%
Hypertension
17%
Electrocardiogram QT prolonged
17%
Trigeminal neuralgia
17%
Purpura
17%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin
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 1
~10
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,252 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,723 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards are associated with Belantamab mafodotin?
"Taking into account the lack of evidence regarding efficacy, Belantamab mafodotin was assigned a safety score of 2."
Answered by AI
What is the current participant count for this experiment?
"As of October 29th 2021, this trial is no longer enrolling patients. It was first posted on April 30th 2022 and has not been edited since then. Fortunately, 859 trials are available for those seeking treatment for multiple myeloma and a further 293 studies require participants taking Belantamab mafodotin."
Answered by AI
What maladies is Belantamab mafodotin typically employed to treat?
"Belantamab mafodotin is widely used to combat chronic lymphocytic leukemia, but may also be deployed for those with amyloidosis or relapsed/refractory multiple myeloma who have received at least two prior systemic chemotherapy regimens."
Answered by AI
Is enrollment still open for this clinical investigation?
"On clinicaltrials.gov, this medical experiment is not currently enrolling patients; the trial was first posted to the website on April 30th 2022 and lately updated October 29th 2021. Nonetheless, 1152 other studies are actively searching for participants presently."
Answered by AI
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