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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 below
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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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My organs are working well.
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I am able to care for myself but cannot do any heavy physical work.
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I recently had my first stem cell transplant for multiple myeloma.
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My cancer shows signs of responding to treatment or is undetectable.
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I will not donate sperm during and for 4 weeks after my last dose of lenalidomide.
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I am between 18 and 75 years old.
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I agree not to donate blood while on lenalidomide and for 28 days after.

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
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.

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
2,966 Previous Clinical Trials
1,804,687 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

Belantamab mafodotin Clinical Trial Eligibility Overview. Trial Name: NCT05091372 — Phase 2
Multiple Myeloma Research Study Groups: Belantamab mafodotin, Lenalidomide
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT05091372 — Phase 2
Belantamab mafodotin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091372 — Phase 2

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
~38 spots leftby Mar 2025