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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma

Phase 1
Recruiting
Led By Hans Lee
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
Patients must be diagnosed with high-risk smoldering multiple myeloma (SMM) as confirmed by bone marrow plasmacytosis with ≥ 10% plasma cells, immunoparesis, and ≥ 95% aberrant plasma cells by flow cytometry
Creatinine clearance (CrCl) ≥ 30 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is designed to find the best dose of Belantamab Mafodotin for safety and efficacy in patients with high-risk smoldering multiple myeloma, with a maximum of 30 patients.

Who is the study for?
This trial is for adults with high-risk smoldering multiple myeloma who haven't had prior treatments. Participants need to have good kidney and liver function, be able to perform daily activities (ECOG 0-2), and agree to contraception. It's not for pregnant women, those with active hepatitis B/C or HIV, recent major surgery patients, or people with heart disease.Check my eligibility
What is being tested?
The study tests Belantamab Mafodotin's safety and optimal dose in two parts: finding the best dose among 18 patients then confirming it in another 12. The main goal is to see how well the drug works against this type of cancer by measuring response rates.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions related to immune system activation, infusion-related symptoms, organ inflammation due to antibody-drug conjugates like Belantamab Mafodotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high-risk smoldering multiple myeloma with specific blood and bone marrow conditions.
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My kidneys are working well enough (CrCl ≥ 30 ml/min).
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I agree to use contraception and not donate sperm.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have smoldering myeloma and haven't been treated for it yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the recommended Phase 2 dose (RP2D) or maximum tolerated dose of single agent belantamab mafodotin in high risk SMM.

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04177823
67%
Platelet count decreased
67%
Blood lactate dehydrogenase increased
67%
Lymphocyte 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

1Treatment groups
Experimental Treatment
Group I: Belantamab mafodotinExperimental Treatment1 Intervention
belantamab mafodotin by vein over 30-60 minutes on Day 1 of each 56-day cycle for the first 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,316 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,787 Patients Enrolled for Multiple Myeloma
Hans LeePrincipal InvestigatorM.D. Anderson Cancer Center
Elisabet ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for individuals to join this research initiative?

"According to the clinicaltrials.gov website, this medical examination is actively recruiting participants; it was first released on May 18th 2022 and updated lastly on September 7th 2021."

Answered by AI

Does this research mark a pioneering moment for its field?

"Currently, there are 33 ongoing studies of Belantamab mafodotin taking place in 221 cities and 34 nations. This pharmaceutical product's first trial began back in 2015 under the auspices of Karyopharm Therapeutics Inc. The Phase 1 & 2 examination concluded after analyzing 518 participants and since then, two additional clinical trials have been conducted."

Answered by AI

What is the common application of Belantamab mafodotin?

"Belantamab mafodotin can be leveraged to modulate the immune system, treat pre-existing proteasome inhibitor conditions, and manage relapsed or resistant multiple myeloma."

Answered by AI

How many individuals can participate in this experiment?

"Affirmative, according to clinicaltrials.gov's records this trial has been actively recruiting since it was posted on May 18th 2022 and is currently in need of 30 patients from a single site."

Answered by AI

Have any prior experiments explored the effects of Belantamab mafodotin?

"At present, 33 studies regarding Belantamab mafodotin are in progress, with 4 of those being advanced to Phase 3. Even though the bulk of these trials are situated in Charlotte, North carolina, 875 other sites worldwide have taken part in this research endeavour."

Answered by AI

What adverse effects have been observed with Belantamab mafodotin treatment?

"The safety profile of Belantamab mafodotin is less established, so it received a score of 1. This result reflects the fact that this medication is currently in Phase 1 trials, meaning there are limited clinical data to support its efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
2022. "A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05055063.
~18 spots leftby Feb 2027
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