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Antibody-drug Conjugate

Belantamab Mafodotin Combinations for Multiple Myeloma (DREAMM 6 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy

Have undergone stem cell transplant (SCT), or are considered transplant ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4.5 years

Awards & highlights

DREAMM 6 Trial Summary

This trial will test the safety and effectiveness of a new drug, belantamab mafodotin, when used in combination with either Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone, in patients with RRMM who have relapsed or are refractory to at least one line of approved therapy.

Who is the study for?

Adults with relapsed/refractory Multiple Myeloma who've had at least one prior treatment can join this trial. They must have measurable disease, be in good physical condition (ECOG 0-1 for Arm A, ECOG 0-2 for Arm B), and not have severe organ damage or active infections. Women of childbearing potential must use effective contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of GSK2857916 combined with Lenalidomide plus Dexamethasone (Arm A) or Bortezomib plus Dexamethasone (Arm B). It has two parts: dose escalation to find a safe dosage and then further evaluation of that dosage's clinical activity.See study design

What are the potential side effects?

Possible side effects include eye problems, infusion reactions, blood disorders, fatigue, infection risk increase, and organ inflammation. Specific side effects may depend on whether patients are in Arm A or Arm B due to different combination therapies.

DREAMM 6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has worsened despite having at least one treatment.

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I have had a stem cell transplant or am not eligible for one.

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I have been diagnosed with Multiple Myeloma.

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I am not pregnant, can test before treatment, and will use birth control during and after the study.

DREAMM 6 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 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

Number of participants with AEs and SAEs in Part 2

Number of participants with AEs and serious adverse events (SAEs), Part 1

Number of participants with DLTs, Part 1, Treatment A

+7 more

Secondary outcome measures

AUC for Bortezomib, Part 1 and 2, Treatment B

AUC for Lenalidomide, Part 1 and 2, Treatment A

AUC for belantamab mafodotin, Part 1 and 2, Treatment B

+23 more

DREAMM 6 Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Belantamab mafodotin+bortezomib+dexamethasoneExperimental Treatment3 Interventions

Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 & 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 & 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 & so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, & so on). Bortezomib will be administered at 1.3 mg/m^2 SC/IV on Days 1,4,8, & 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, & 12 of every 21-day cycle.

Group II: Arm A: Belantamab mafodotin+lenalidomide +dexamethasoneExperimental Treatment3 Interventions

Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, & 22 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

Bortezomib

2005

Completed Phase 2

~1140

Belantamab mafodotin

2019

Completed Phase 1

~10

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,751 Previous Clinical Trials

8,067,320 Total Patients Enrolled

47 Trials studying Multiple Myeloma

6,281 Patients Enrolled for Multiple Myeloma

Iqvia Pty LtdIndustry Sponsor

106 Previous Clinical Trials

169,856 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,778 Total Patients Enrolled

25 Trials studying Multiple Myeloma

3,252 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Antibody-drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03544281 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Arm B: Belantamab mafodotin+bortezomib+dexamethasone, Arm A: Belantamab mafodotin+lenalidomide +dexamethasone

Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT03544281 — Phase 1 & 2

Belantamab mafodotin (Antibody-drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03544281 — Phase 1 & 2

Frequently Asked Questions

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

How many people are being signed up for this research project?

"This research is no longer recruiting patients. The trial was originally posted on September 20th, 2018 and was last edited on November 2nd, 2022. However, there are 827 other trials for multiple myeloma and 781 trials for Belantamab mafodotin that are currently seeking participants."

Answered by AI

What disease does Belantamab mafodotin target?

"ophthalmia, sympathetic can be effectively treated with Belantamab mafodotin. This medication is also known to help patients who have undergone at least two rounds of systemic chemotherapy, branch retinal vein occlusion, and macular edema."

Answered by AI

Are there different versions of this trial taking place in different states?

"Currently, there are 16 trial sites active. They are located in cities such as Indianapolis, East Setauket and Greenville amongst other locations. If you wish to enroll, it may be more convenient for you to select a site closer to your location in order to reduce travel-related demand"

Answered by AI

Are we still taking patients for this experiment?

"According to the information available on clinicaltrials.gov, this study is not looking for candidates at the moment. The trial was first posted on September 20th, 2018 and was last edited on November 2nd, 2022. Even though this specific study is not actively recruiting right now, there are 1,608 other studies that are currently seeking participants."

Answered by AI

Could you please direct me to other research that has looked at Belantamab mafodotin?

"The first clinical trial studying belantamab mafodotin took place in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been a total of 1612 completed trials worldwide. Currently, there are 781 active studies with a large number based out of Indianapolis, Indiana."

Answered by AI

What are the investigators hoping to discover through this research?

"The main objective of this study is to monitor the Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM), Part 2. The study will last for approximately 4.5 years and secondary objectives include Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30), Part 1 and 2, Change from Baseline in symptoms and impacts as measured by the"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

2018. "To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03544281.

All > Lenalidomide > Revlimid