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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma (DREAMM 13 Trial)

Phase 1
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status 0-2
Participants with histologically or cytologically confirmed diagnosis of multiple myeloma, as defined in International Myeloma Working Group criteria and has failed at least 1 prior line of anti-myeloma treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

DREAMM 13 Trial Summary

This trial will look at the effects of a new cancer drug in patients with and without liver problems.

Who is the study for?
Adults with Multiple Myeloma who've had at least one prior treatment can join this trial. They must have a certain level of organ function and be able to consent. Women and men must use contraception, and those with previous stem cell transplants or specific viral exposures may qualify under conditions.Check my eligibility
What is being tested?
The study is testing Belantamab Mafodotin's effects on patients with different liver functions. It aims to understand how the drug moves in the body, its safety, and tolerability in those with normal liver function versus those with impairments.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision or dry eyes (corneal issues), low blood counts which can increase infection risk or cause fatigue, skin reactions, infusion-related reactions, and possible liver enzyme changes.

DREAMM 13 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have multiple myeloma and previous treatments haven't worked.

DREAMM 13 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Part 1 and Part 2: AUC(0-168 hours) of cys-mcMMAF
Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)
Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)of total mAb
+14 more
Secondary outcome measures
Part 1 and Part 2: Change from Baseline in Vital Sign- Heart rate (beats per minute)
Part 1 and Part 2: Change from Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeters of mercury [mmHg])
Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
+3 more

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04177823
67%
Blood lactate dehydrogenase increased
67%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Hyponatraemia
50%
Hypocalcaemia
50%
Pyrexia
50%
White blood cell count decreased
50%
Aspartate aminotransferase increased
50%
Neutrophil count decreased
50%
Hyperphosphataemia
33%
Alanine aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Hypercalcaemia
33%
Hyperuricaemia
33%
Hypokalaemia
33%
Hypomagnesaemia
33%
Punctate keratitis
33%
Vision blurred
17%
Gamma-glutamyltransferase increased
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%
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

DREAMM 13 Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2,Group 3: Participants with severe hepatic impairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment (Serum bilirubin >3 times ULN and any AST) will be administered with Belantamab mafodotin
Group II: Part 1, Group 2: Participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment (Serum bilirubin greater than >1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin
Group III: Part 1, Group 1: Participants with normal hepatic functionExperimental Treatment1 Intervention
Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase [AST] less than or equal to [<=] Upper limit of normal [ULN]) will be administered with Belantamab mafodotin
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?

GlaxoSmithKlineLead Sponsor
4,763 Previous Clinical Trials
8,104,685 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,405 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,259 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,376 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab Mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04398680 — Phase 1
Multiple Myeloma Research Study Groups: Part 1, Group 1: Participants with normal hepatic function, Part 2,Group 3: Participants with severe hepatic impairment, Part 1, Group 2: Participants with moderate hepatic impairment
Multiple Myeloma Clinical Trial 2023: Belantamab Mafodotin Highlights & Side Effects. Trial Name: NCT04398680 — Phase 1
Belantamab Mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04398680 — Phase 1

Frequently Asked Questions

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

Does this investigation mark a pioneering foray into new medical terrain?

"Belantamab mafodotin investigation has spanned over five years, beginning with a Phase 1 & 2 drug trial in 2015 sponsored by Karyopharm Therapeutics Inc. This initial study included 518 participants and successfully led to international approval for the medication. Currently there are 33 active studies located across 221 cities of 34 countries around the world."

Answered by AI

Has Belantamab mafodotin been given the green light by the FDA?

"Belantamab mafodotin is deemed to be a relatively safe drug based on clinical research and, thus, receives a score of 1."

Answered by AI

What is the common application of Belantamab mafodotin?

"Belantamab mafodotin can be utilized to modulate the immune system and treat a variety of ailments, such as those resulting from prior anti-cd38 monoclonal antibody treatment or proteasome inhibitor use. It is also effective in managing relapsed or refractory multiple myeloma cases."

Answered by AI

How many study participants have joined this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this study, which was originally posted on April 20th 2021, is actively seeking participants. A total of 28 people are being recruited from 10 distinct sites."

Answered by AI

Are there any other experiments that have implemented Belantamab mafodotin?

"Presently, 33 research initiatives are underway involving Belantamab mafodotin, 4 of which have reached Phase 3. Though most of the trials take place in Charlotte North carolina, there are 875 other medical centres conducting studies for this drug."

Answered by AI

Is this investigation currently recruiting participants?

"Affirmative. Clinical trials.gov reveals that this medical trial is actively searching for enrollees, with the first post dated April 20th 2021 and last edit on November 29 2022. The initiative requires 28 individuals to be recruited from 10 different clinical sites."

Answered by AI

Are there any research centers in North America conducting this trial?

"Presently, the trial is available at 10 medical institutes. These are located in Tucson, Monroeville, Chicago and other cities across America; it's best to pick a site that minimizes your need for travel if you decide to take part."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function
2021. "A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398680.
~9 spots leftby Nov 2025
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