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Belantamab Mafodotin for Multiple Myeloma

Phase 1
Recruiting
Led By Neeraj Saini
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test if Blenrep can help prevent MM from recurring after an AutoSCT, as well as study the drug's safety post-transplant.

Who is the study for?
This trial is for adults aged 18-75 with relapsed/refractory multiple myeloma after at least two prior treatments, including specific standard agents. Participants must have a partial response or better to previous therapies, adequate blood counts and organ function, and no history of certain other diseases or recent monoclonal antibody treatment.Check my eligibility
What is being tested?
The study tests if Belantamab Mafadotin (Blenrep) can prevent the return of multiple myeloma after an autologous stem cell transplant. It also examines the drug's safety post-transplant in patients who've had this type of therapy before or are undergoing it for the first time.See study design
What are the potential side effects?
Potential side effects include vision issues like blurry eyesight due to corneal problems, low blood cell counts which could increase infection risk or cause fatigue, liver enzyme changes suggesting liver damage, and infusion-related reactions.

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
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belantamab mafodotinExperimental Treatment1 Intervention
belantamab mafodotin by vein over 30 minutes every 8 weeks
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
2,972 Previous Clinical Trials
1,787,297 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,797 Patients Enrolled for Multiple Myeloma
Neeraj SainiPrincipal InvestigatorM.D. Anderson Cancer Center
Neeraj Saini, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Belantamab mafodotin Clinical Trial Eligibility Overview. Trial Name: NCT05065047 — Phase 1
Multiple Myeloma Research Study Groups: Belantamab mafodotin
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT05065047 — Phase 1
Belantamab mafodotin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065047 — Phase 1

Frequently Asked Questions

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

What are the most common reasons that patients take Belantamab mafodotin?

"Belantamab mafodotin is used to change the activity of the immune system and can also be effective in treating relapsed or refractory multiple myeloma, as well as patients that have undergone treatment with a proteasome inhibitor or an anti-cd38 monoclonal antibody."

Answered by AI

Is this research unique in any way?

"There are 33 ongoing studies worldwide for the efficacy of Belantamab mafodotin. The first study, which was sponsored by Karyopharm Therapeutics Inc, had 518 participants and completed Phase 1 & 2 in 2015. Since then, there have been 2 more completed studies."

Answered by AI

Have there been any breakthroughs in Belantamab mafodotin's approval process?

"Belantamab mafodotin's safety is only supported by limited data, as this trial is in its first phase."

Answered by AI

How many people will be given the chance to participate in this clinical trial?

"This study has already wrapped up recruitment and is no longer looking for patients. The trial was first posted on 8/30/2022 and ended on 7/31/2022. There are many other active studies, with 826 trials currently underway for multiple myeloma and 33 specifically for Belantamab mafodotin."

Answered by AI

What is the historical efficacy of Belantamab mafodotin in similar cases?

"At the moment, there are 33 ongoing studies into Belantamab mafodotin. 4 of those clinical trials are in their third and final phase. The majority of studies for Belantamab mafodotin take place in Poitiers cedex and Alberta; however, 875 different locations are running trials for this treatment."

Answered by AI

Are there opportunities for new patients to join this clinical trial?

"As of 7/31/2022, this particular trial is no longer recruiting patients. The study was originally posted on 8/30/20222 and has since been edited. For individuals exploring other studies, 826 trials are actively searching for patients with multiple myeloma while 33 studies are actively admitting patients for Belantamab mafodotin treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma
2023. "Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05065047.
~9 spots leftby May 2025
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