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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma (EMBRACE Trial)

Phase 2
Led By Saurabh Chhabra, MD, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of multiple myeloma with measurable disease prior to receiving CAR-T
Age ≥ 18 years
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

EMBRACE Trial Summary

This trial is testing a new drug, belantamab mafodotin, as a possible treatment for multiple myeloma that has returned or does not respond to other treatments. The drug will be given as an IV on day 1 of each cycle, and the trial will last for 56 days.

Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had at least three prior treatments and stable disease post-CAR-T therapy. They must have good organ function, not be pregnant or breastfeeding, use contraception, and have no history of severe reactions to belantamab mafodotin or similar drugs.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a drug called Belantamab Mafodotin as maintenance therapy after CAR-T cell treatment in patients with multiple myeloma. Participants will receive this drug every two months following their initial CAR-T therapy.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision, dry eyes; blood disorders; infusion-related reactions; fatigue; nausea; fever; respiratory infections. The severity can vary from mild to serious.

EMBRACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have multiple myeloma that can be measured and am about to receive CAR-T therapy.
I am 18 years old or older.
I've had 3 treatments before CAR-T and haven't worsened after CAR-T.
I am using birth control as required by my local laws.
My blood tests show enough hemoglobin, platelets, and neutrophils.
I had a transplant from another person over a year ago and may be treating skin GVHD.
I agree not to donate sperm and to use birth control or abstain from sex.
My condition hasn't worsened after receiving CAR-T therapy.
My liver tests are within the normal range.
I am a male and will use the required contraception methods.
I have taken a pregnancy test recently and it was negative.
I am able to care for myself and perform daily activities.

EMBRACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of patients with 12-month progression-free survival.
Secondary outcome measures
Overall survival for the entire study population from the time of CAR-T administration.

EMBRACE Trial Design

1Treatment groups
Experimental Treatment
Group I: belantamab mafodotinExperimental Treatment1 Intervention
Belantamab mafodotin is an intravenous drug.
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
Completed Phase 1

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,538 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,681 Patients Enrolled for Multiple Myeloma
Saurabh Chhabra, MD, MSPrincipal InvestigatorMedical College of Wisconsin
Meera Mohan, MD, MSPrincipal InvestigatorMedical College of Wisconsin

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05117008 — Phase 2
Multiple Myeloma Research Study Groups: belantamab mafodotin
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT05117008 — Phase 2
Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05117008 — Phase 2

Frequently Asked Questions

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

To what extent has this clinical trial been populated with participants?

"Affirmative. Clinicaltrials.gov displays information that this trial, which was first made available on July 19th 2022, is still recruiting patients to participate. 45 individuals are being sought from a single centre of inquiry."

Answered by AI

Have there been any prior reports on Belantamab mafodotin's efficacy?

"Currently, 33 clinical trials are being conducted to explore the efficacy of Belantamab mafodotin. Of those studies 4 have reached phase 3 and many of these experiments originate from Poitiers cedex, Baden-Wuerttemberg; however 875 different sites around the world are participating in its investigation."

Answered by AI

Is this trial currently open to participants?

"According to the data published on clinicaltrials.gov, this experiment is currently open for recruitment and was last modified on August 3rd 2022. The trial initially went live July 19th of the same year."

Answered by AI

Is Belantamab mafodotin a secure treatment for patients?

"This Phase 2 trial has yielded some evidence of Belantamab mafodotin's safety, rendering the compound a score of two on our team at Power's scale. However, there is yet to be data confirming its efficacy."

Answered by AI

Does this clinical trial represent an unprecedented approach to treatment?

"Currently, there are 33 active trials for Belantamab mafodotin in 221 cities and 34 nations. This drug first entered into clinical studies back in 2015 when Karyopharm Therapeutics Inc sponsored a Phase 1 & 2 trial with 518 volunteers. Since then, two more studies have been conducted."

Answered by AI

What is the primary application of Belantamab mafodotin?

"Belantamab mafodotin has a range of therapeutic applications, including immunomodulation and the management of relapsed or refractory multiple myeloma in addition to other conditions linked to previous proteasome inhibitor treatment and anti-cd38 monoclonal antibody therapy."

Answered by AI
~27 spots leftby Jan 2027