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Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma (DREAMM12 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 (ECOG) performance status 0-2
Participants with histologically or cytologically confirmed diagnosis of MM, as defined in International Myeloma Working Group criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
DREAMM12 Trial Summary
This trial is testing a new drug to treat MM. The drug is given intravenously once every 3 weeks. The trial will last up to 48 months and will test the safety, tolerability, and pharmacokinetics of the drug in MM patients with different levels of renal impairment.
Who is the study for?
This trial is for adults with multiple myeloma who've had at least 3 prior treatments (or 2 if they couldn't have a stem cell transplant) and have varying degrees of kidney function, including severe impairment or end-stage renal disease. Participants must be able to consent, follow study rules, and use contraception.Check my eligibility
What is being tested?
The trial tests belantamab mafodotin monotherapy in multiple myeloma patients with different levels of kidney health. It's given intravenously every three weeks. The study has two parts based on the severity of renal dysfunction and includes screening, treatment, follow-up, and continued treatment phases.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells (infusion reactions), eye problems like blurry vision or dry eyes (corneal issues), blood disorders such as low platelet counts or anemia, fatigue, nausea, and increased risk of infections.
DREAMM12 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
Select...
My condition is officially diagnosed as multiple myeloma.
DREAMM12 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: AUC over the dosing interval (AUC[0-tau]) of GSK2857916
Part 1: AUC(0-168 hours) of cys-mcMMAF
Part 1: AUC(0-tau) of total mAb
+31 moreSecondary 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) (millimeter of mercury [mmHg])
Part 1 and Part 2: Change from baseline in physical examination parameter
+2 moreSide effects data
From 2022 Phase 1 trial • 6 Patients • NCT0417782367%
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%
Myelosuppression
17%
Liver injury
17%
Adenosine deaminase increased
17%
Blood creatine phosphokinase increased
17%
Alpha hydroxybutyrate dehydrogenase increased
17%
Electrocardiogram QT prolonged
17%
Glycocholic acid increased
17%
Protein total decreased
17%
Crystal urine present
17%
Gamma-glutamyltransferase increased
17%
Leucine aminopeptidase increased
17%
Hyperglycaemia
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%
Trigeminal neuralgia
17%
Lung disorder
17%
Purpura
17%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin
DREAMM12 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2: Participants with ESRD (on hemodialysis)Experimental Treatment1 Intervention
Participants with ESRD (iGFR: <15 mL/min) on hemodialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Group II: Part 2: Participants with ESRD (not on dialysis)Experimental Treatment1 Intervention
Participants with ESRD (iGFR: <15 mL/min) not on dialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Group III: Part 1: Participants with severe renal impairmentExperimental Treatment1 Intervention
Participants with severely impaired renal function (iGFR: 15-29 mL/min) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Group IV: Part 1: Participants with normal/mild impaired renal functionExperimental Treatment1 Intervention
Participants with normal or mildly impaired renal function (Normal: individual glomerular filtration rate [iGFR]: >=90 milliliter per minute; Mild impairment: iGFR: 60-89 mL/min will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
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
4,753 Previous Clinical Trials
8,069,422 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,397 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,894 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,368 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs within the last 14 days or 5 half-lives, whichever is shorter.I am using birth control as required by local laws for clinical study participants.I have had a stem cell transplant from a donor.I have not undergone plasmapheresis within the last week.I am at least 18 years old, or 19 if I am from the Republic of Korea.I have only MM or any other cancer I had has been stable for 2+ years.I am following local guidelines for contraception during the study.My kidney problems are due to liver disease.I have previously been treated with belantamab mafodotin.I have a mild eye surface condition, not severe corneal disease.I am currently experiencing bleeding from an internal organ or mucosa.You've had a bad reaction to drugs similar to belantamab mafodotin.You have a way to measure the disease, such as through a blood or urine test.I have had a stem cell transplant using my own cells and meet specific criteria.My liver condition is currently stable.I am HIV positive.I have a risk for heart disease.My organs are functioning well.I am able to care for myself and perform daily activities.My condition is officially diagnosed as multiple myeloma.I do not have Hepatitis B, or if I do, I meet the specific criteria for inclusion.I am currently being treated for an infection.I have active plasma cell leukemia, amyloidosis, POEMS syndrome, or Waldenstrom Macroglobulinemia.I am currently pregnant or breastfeeding.I don't have major side effects from past treatments, except for hair loss or mild nerve issues.I have not had any major surgery in the last 4 weeks.I tested positive for hepatitis C recently or in the last 3 months.I haven't taken strong OATP inhibitors recently.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Participants with normal/mild impaired renal function
- Group 2: Part 1: Participants with severe renal impairment
- Group 3: Part 2: Participants with ESRD (not on dialysis)
- Group 4: Part 2: Participants with ESRD (on hemodialysis)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the eligibility criteria for enrolling in this research endeavor?
"Per information on clinicaltrials.gov, this research endeavour is still in need of enrollees. It was originally listed on October 9th 2020 and the most recent update was made November 1st 2022."
Answered by AI
How extensive is the current enrollment of this clinical trial?
"Affirmative, the information available on clinicaltrials.gov confirms that this study is actively searching for participants. This trial was initially announced on October 9th 2020 and had its most recent edit take place November 1st 2022, with a total of 36 individuals required from 20 different medical centres."
Answered by AI
What potential risks can be associated with Belantamab mafodotin treatment?
"As this is a Phase 1 trial, the safety of Belantamab mafodotin has been assessed to be level 1 due to limited data regarding its efficacy and risk."
Answered by AI
Are there any preceding investigations that have explored the effects of Belantamab mafodotin?
"Belantamab mafodotin was first researched in 2015 at Weill Cornell Medicine/New york Presbyterian Hospital. Over the past 6 years, two trials have been completed and there currently exists 33 active studies, with many being conducted out of Plantation Florida."
Answered by AI
Has a comparable clinical experiment been conducted prior to this one?
"As of now, there are 33 live Belantamab mafodotin studies being conducted in 221 cities and 34 countries. The trailblazing trial for this medication was launched by Karyopharm Therapeutics Inc back in 2015 with 518 participants taking part. Since then, two more completions have been recorded."
Answered by AI
What maladies is Belantamab mafodotin usually prescribed for?
"Belantamab mafodotin can be prescribed to patients with immunomodulation, a history of proteasome inhibitor treatment, and those that have relapsed or failed to respond other treatments for multiple myeloma."
Answered by AI
How many localities are managing this trial?
"Currently, 20 sites across the continent are taking part in this clinical trial. Offering accessibility to patients, there are locations in Plantation, Tucson and Beverly Hills while other centres can be found nearby. To reduce travel time it is best to select a spot close by your residence if you choose to participate."
Answered by AI
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