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Belantamab Mafodotin + SoC for Multiple Myeloma (DREAMM 9 Trial)
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.
DREAMM 9 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDREAMM 9 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DREAMM 9 Trial Design
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Who is running the clinical trial?
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- I am able to understand and sign the consent form.You cannot tolerate or should not take medication to prevent viral infections.I am at risk for heart disease.I am considered fit for high dose chemotherapy with stem cell transplant.I cannot undergo intense chemotherapy with stem cell transplant due to other health issues.I do not have any serious health or mental conditions that could affect my safety in the trial.I have a kidney condition, but it's only protein in my urine due to my multiple myeloma.I am HIV positive.You have hepatitis B or C infection.You have had a bad reaction to drugs similar to belantamab mafodotin in the past.I cannot tolerate blood clot prevention medication.You must have a specific type of disease that can be measured according to certain guidelines.I have had treatment for my multiple myeloma or smoldering multiple myeloma, except for emergency steroids or targeted radiation.I do not have active liver or biliary disease, with certain exceptions.I have not undergone plasmapheresis within the last week.My organ functions are within normal ranges according to recent tests.I have been diagnosed with multiple myeloma and need treatment.I am currently being treated for an infection.My multiple myeloma has affected my brain or spinal cord.I have ongoing bleeding inside my body that treatments haven't stopped.I am able to get out of my bed or chair and move around.I have had cancer before, but not multiple myeloma or the exceptions listed.I have AL amyloidosis, POEMS syndrome, or active plasma cell leukemia.I am using effective birth control methods if there's any chance of pregnancy.I have not had major surgery in the last 4 weeks.I have a mild eye surface condition, but no serious corneal disease.I have moderate to severe nerve pain or damage.I am over 18 years old.I have been diagnosed with smoldering multiple myeloma.
- Group 1: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd
- Group 2: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd
- Group 3: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd
- Group 4: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd
- Group 5: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd
- Group 6: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd
- Group 7: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd
- Group 8: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd
- Group 9: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd
- Group 10: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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."
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