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Monoclonal Antibodies
Belantamab Mafodotin vs. Daratumumab for Multiple Myeloma (DREAMM 7 Trial)
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria
Must have at least 1 aspect of measurable disease, defined as one of the following: Urine M-protein excretion >=200 mg per 24-hour, Serum M-protein concentration >=0.5 grams per deciliter (g/dL), Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 74 months
Awards & highlights
DREAMM 7 Trial Summary
This trial is comparing two different treatments for relapsed myeloma. One is the standard of care, daratumumab + bortezomib/dexamethasone, and the other is a new drug, belantamab mafodotin, + bortezomib/dexamethasone. The trial will evaluate how well each works and if one is better than the other.
Who is the study for?
This trial is for people with multiple myeloma who've had at least one prior treatment and whose disease has gotten worse after their most recent therapy. They must have good organ function, a performance status showing they can handle daily activities, and measurable signs of the disease. People with eye diseases affecting the cornea, intolerance to certain drugs used in this study, ongoing severe nerve pain or damage, previous treatments targeting BCMA or an allogenic stem cell transplant cannot join.Check my eligibility
What is being tested?
The study compares two combinations of cancer drugs in patients with relapsed multiple myeloma: Belantamab Mafodotin with Bortezomib/Dexamethasone versus Daratumumab with Bortezomib/Dexamethasone. It's randomized and open-label so participants know which treatment they're getting.See study design
What are the potential side effects?
Possible side effects include eye problems like blurry vision due to belantamab mafodotin; infections, fatigue, nausea from bortezomib; infusion reactions from daratumumab; and weight gain or mood changes from dexamethasone.
DREAMM 7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma according to IMWG standards.
Select...
My cancer can be measured by specific blood or urine tests.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My multiple myeloma has worsened despite having at least one treatment.
DREAMM 7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 74 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 74 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Change from Baseline in HRQoL as measured by EORTC IL52, 20-Item Multiple Myeloma Module (QLQ-MY20)
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)
Clinical Benefit Rate (CBR)
+16 moreSide effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
DREAMM 7 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)Experimental Treatment3 Interventions
Group II: Daratumumab and Bortezomib plus Dexamethasone (Arm B)Active Control3 Interventions
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
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,066,881 Total Patients Enrolled
47 Trials studying Multiple Myeloma
5,862 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,359 Total Patients Enrolled
25 Trials studying Multiple Myeloma
2,833 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can't tolerate bortezomib or my condition worsened on it.My condition worsened during or within 2 months after anti-CD38 therapy.All my previous cancer treatment side effects are mild, except for hair loss.I have had a stem cell transplant from a donor.My organs are working well.I have ongoing nerve pain or damage that affects my daily activities.I have been diagnosed with multiple myeloma according to IMWG standards.I have previously received anti-BCMA therapy.My cancer can be measured by specific blood or urine tests.I do not have any serious health issues like kidney, liver, heart diseases, or severe mental health problems.I can take care of myself and am up and about more than half of my waking hours.I have a disease affecting the outer layer of my eye.You cannot tolerate daratumumab.My multiple myeloma has worsened despite having at least one treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
- Group 2: Daratumumab and Bortezomib plus Dexamethasone (Arm B)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 conditions does Bortezomib typically alleviate?
"Bortezomib is most commonly used to treat ophthalmia and sympathetic. It has also been shown to be effective in treating branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
How many individuals are being treated as part of this study?
"Unfortunately, this study is not admitting any more patients at the moment. The listing was made on May 7th 2020 and edited September 23rd 2022. There are 826 other trials for multiple myeloma and 695 studies involving Bortezomib that are currently looking for candidates."
Answered by AI
Has Bortezomib been cleared by the FDA?
"Bortezomib is thought to be safe based on its Phase 3 status, which includes some data backing up the efficacy of the drug as well as multiple rounds of safety testing."
Answered by AI
Where are patients able to enroll in this trial?
"There are currently 20 sites enrolling patients in this trial, which include locations in Farmington, Tyler and Cincinnati. To reduce the inconvenience of travel, please select the location nearest to you."
Answered by AI
Are there still places available for participants in this clinical trial?
"The clinical trial in question is not recruiting patients at this time, as evidenced by the information on clinicaltrials.gov. The trial was posted on 5/7/2020 and last updated on 9/23/2022. There are 1521 other trials that are actively looking for participants right now."
Answered by AI
What is the history of Bortezomib in medical research?
"Bortezomib was first researched in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been a total of 1407 completed clinical trials worldwide. As of now, 695 studies are ongoing with many of them based in Farmington, Utah."
Answered by AI
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