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Monoclonal Antibodies

Belantamab Mafodotin + SoC for Multiple Myeloma (DREAMM 9 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
Capable of giving signed informed consent
Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to presence of significant comorbid condition(s), as judged by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to an average of 54 months
Awards & highlights

DREAMM 9 Trial Summary

This trial will test the safety and effectiveness of a new drug, belantamab mafodotin, in combination with other drugs, for people with newly diagnosed multiple myeloma.

Who is the study for?
Adults over 18 with newly diagnosed multiple myeloma needing treatment, not eligible for stem cell transplant due to other health issues. They must have measurable disease, be able to perform daily activities (ECOG 0-2), and have proper organ function. Participants must use contraception and give informed consent. Excluded are those with active bleeding, liver disease, heart risks, infections requiring treatment, certain allergies or previous cancers (with exceptions), recent major surgery or therapy for multiple myeloma.Check my eligibility
What is being tested?
The trial tests Belantamab Mafodotin combined with standard drugs Bortezomib, Lenalidomide & Dexamethasone in adults with new multiple myeloma. The study will find the safest dose of Belantamab Mafodotin when given every 3-12 weeks alongside a regimen of the other drugs on specific cycles up to cycle 8 and then less frequently.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision or dry eyes (corneal issues), blood disorders such as low platelet counts or anemia, fatigue, nausea and vomiting from chemotherapy drugs; risk of infection may increase due to immune system suppression.

DREAMM 9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to understand and sign the consent form.
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I cannot undergo intense chemotherapy with stem cell transplant due to other health issues.
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My organ functions are within normal ranges according to recent tests.
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I have been diagnosed with multiple myeloma and need treatment.
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I am able to get out of my bed or chair and move around.
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I am using effective birth control methods if there's any chance of pregnancy.
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I am over 18 years old.

DREAMM 9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to an average of 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to an average of 54 months 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 adverse events (AEs) and serious adverse events (SAEs)
Number of participants with dose-limiting toxicities (DLTs)
Secondary outcome measures
AUC of cys-mcMMAF
Area under the concentration time curve (AUC) of belantamab mafodotin
Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd
+9 more

DREAMM 9 Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group II: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group III: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group IV: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group V: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group VI: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
Group VII: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
Group VIII: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
Group IX: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
Group X: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,748 Previous Clinical Trials
8,067,368 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,435 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,834 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,260 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04091126 — Phase 1
Multiple Myeloma Research Study Groups: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd, Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd, Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd, Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd, Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd, Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd, Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd, Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd, Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd, Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT04091126 — Phase 1
Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04091126 — Phase 1

Frequently Asked Questions

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

What conditions does Belantamab mafodotin commonly alleviate?

"Belantamab mafodotin is often administered as a treatment for ophthalmia, sympathetic. Additionally, this medication has been found to be advantageous in the management of conditions such as macular edema, branch retinal vein occlusion and individuals that have experienced at least two prior systemic chemotherapy regimens."

Answered by AI

What outcomes is this experiment hoping to bring about?

"The study sponsor, GlaxoSmithKline has outlined that the primary endpoints for this trial will be Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), as measured over a three Treatment Cycle period. Secondary objectives include examining Cmax of total monoclonal antibody concentration via blood sampling at specific time points, AUC of monoclonal antibody concentration through similar blood testing, and Maximum plasma concentration levels of belantamab mafodotin also determined by collecting patients' blood samples."

Answered by AI

What potential adverse effects can Belantamab mafodotin put patients at risk for?

"The safety of Belantamab mafodotin is rated at 1, due to the preliminary data available for both its efficacy and security. This assessment is based on it being a Phase 1 trial."

Answered by AI

Are there current vacancies to join this research endeavor?

"Indeed, the data published on clinicaltrials.gov affirms that this medical study is presently recruiting participants. This research initiative was first announced on December 18th 2019 and has received its most recent update July 22nd 2022. A total of 144 subjects across seven locations are needed to complete the trial."

Answered by AI

How widely is this clinical experiment being conducted?

"This research is recruiting participants out of 7 sites spread across North America; including Ottawa, Winston-Salem and Westwood. To reduce the burden on patients, it's prudent to select a site close by if they decide to join this trial."

Answered by AI

Could you detail any other studies that have tested the effects of Belantamab mafodotin?

"Currently, Belantamab mafodotin has 750 active clinical trials and 169 of these are in Phase 3. Mishawaka, Indiana is the epicenter for this medication's clinical research but there are 26372 other sites conducting trials around the globe."

Answered by AI

What is the maximum capacity of patients that can participate in this medical experiment?

"Affirmative, clinicaltrials.gov exhibits that this experiment is presently recruiting volunteers; the study was initially posted on December 18th 2019 and its latest amendment took place on July 22nd 2022. The trial requires 144 participants across 7 different sites to be enrolled in total."

Answered by AI
~27 spots leftby Apr 2025