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Belantamab Mafodotin for Multiple Myeloma (DREAMM 13 Trial)
DREAMM 13 Trial Summary
This trial will look at the effects of a new cancer drug in patients with and without liver problems.
DREAMM 13 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDREAMM 13 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DREAMM 13 Trial Design
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Who is running the clinical trial?
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- My organs are functioning well.I have specific blood, nerve, or skin conditions related to my cancer.You can join the study if you have had a certain type of stem cell transplant in the past.You have HIV under certain conditions.I am using approved methods of contraception.I have not received belantamab mafodotin therapy in the last 90 days.I have a mild eye surface condition, not severe corneal disease.I can take care of myself and am up and about more than half of my waking hours.I have Hepatitis B under certain conditions.I have a history of Hepatitis B, C, or HIV but meet specific health conditions.I have or had cancer other than multiple myeloma, under certain conditions.I don't have major side effects from past treatments, except for hair loss or mild nerve issues.My liver condition is currently stable.You have a condition that can be measured using specific criteria.I am using approved methods of contraception.I am 18 years old or older.I have had a stem cell transplant from a donor.Criterion: Participants with Gilbert's syndrome are excluded.I have multiple myeloma and previous treatments haven't worked.I have a risk for heart disease.I am currently pregnant or breastfeeding.I am currently being treated for an infection.You have tested positive for hepatitis C.
- Group 1: Part 1, Group 1: Participants with normal hepatic function
- Group 2: Part 2,Group 3: Participants with severe hepatic impairment
- Group 3: Part 1, Group 2: Participants with moderate hepatic impairment
- 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
Does this investigation mark a pioneering foray into new medical terrain?
"Belantamab mafodotin investigation has spanned over five years, beginning with a Phase 1 & 2 drug trial in 2015 sponsored by Karyopharm Therapeutics Inc. This initial study included 518 participants and successfully led to international approval for the medication. Currently there are 33 active studies located across 221 cities of 34 countries around the world."
Has Belantamab mafodotin been given the green light by the FDA?
"Belantamab mafodotin is deemed to be a relatively safe drug based on clinical research and, thus, receives a score of 1."
What is the common application of Belantamab mafodotin?
"Belantamab mafodotin can be utilized to modulate the immune system and treat a variety of ailments, such as those resulting from prior anti-cd38 monoclonal antibody treatment or proteasome inhibitor use. It is also effective in managing relapsed or refractory multiple myeloma cases."
How many study participants have joined this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this study, which was originally posted on April 20th 2021, is actively seeking participants. A total of 28 people are being recruited from 10 distinct sites."
Are there any other experiments that have implemented Belantamab mafodotin?
"Presently, 33 research initiatives are underway involving Belantamab mafodotin, 4 of which have reached Phase 3. Though most of the trials take place in Charlotte North carolina, there are 875 other medical centres conducting studies for this drug."
Is this investigation currently recruiting participants?
"Affirmative. Clinical trials.gov reveals that this medical trial is actively searching for enrollees, with the first post dated April 20th 2021 and last edit on November 29 2022. The initiative requires 28 individuals to be recruited from 10 different clinical sites."
Are there any research centers in North America conducting this trial?
"Presently, the trial is available at 10 medical institutes. These are located in Tucson, Monroeville, Chicago and other cities across America; it's best to pick a site that minimizes your need for travel if you decide to take part."
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