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Daratumumab for POEMS Syndrome
Study Summary
This trial is investigating the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with Polyneuropathy, Organomegaly, Endocrinopathy, m Protein Component, Skin Changes (POEMS) syndrome.
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 16 Patients • NCT04070378Trial Design
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- You are allergic to lenalidomide, DARA, or certain other medications and proteins.You have received treatment with a drug called DARA or any other similar drugs that work in a similar way.You have multiple myeloma that has spread to your central nervous system.You have tested positive for HIV.If you have COPD, you need to have a breathing test during screening.Your overall physical condition will not prevent you from participating in the study, even if you have significant limitations due to your medical condition.You have hepatitis C, unless you have been successfully treated and have no detectable virus for at least 12 weeks after treatment.You haven't had any cancer, except for certain types that were treated a long time ago, or other cancers with a good chance of not coming back for at least five years.You have a rare condition called POEMS syndrome, but it has not affected your bone marrow widely, and you only have a single tumor made of certain cells.You have had a heart attack in the past 6 months or have unstable heart conditions that could be risky for joining the study.People who have been recently diagnosed with POEMS syndrome or have had it come back can take part in the study.You must have POEMS syndrome and meet the specific diagnostic criteria for POEMS syndrome as outlined in the study materials.You have severe lung disease (COPD) or uncontrolled asthma, unless the doctor thinks you need the treatment and there are no better options.You have hepatitis B or a history of hepatitis B, unless you have been vaccinated for hepatitis B and have a documented history of the vaccination. If you have been vaccinated, you do not need to be tested for hepatitis B virus DNA.You need to have at least 50,000 platelets per microliter of blood.Your kidneys should be working well, as shown by a serum creatinine level below 3 mg/dL.Your heart's pumping ability, measured by an ECHO or MUGA scan, needs to be at least 40 percent.You are not able to perform everyday activities without help.You have nerve problems that affect your ability to move or feel things.
- Group 1: Daratumumab Injection
- 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 risks can be associated with Daratumumab Injection?
"On a scale of 1 to 3, Daratumumab Injection received a score of 2. This is due the Phase 2 status - there are data supporting safety but not yet any evidence for its efficacy."
How many individuals have been recruited to participate in this trial?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical examination, which was first issued on September 22nd 2020, is actively recruiting. Approximately 10 test subjects ought to be sourced from 1 research facility."
To what health conditions is the Daratumumab Injection typically prescribed?
"Daratumumab Injection is a common intervention for biological response modifiers, and can also be utilized to treat refractory multiple myeloma, relapse cases of the same condition, as well as cellular transplants."
Can you provide an overview of any prior research on Daratumumab Injection?
"Currently, 140 clinical trials are ongoing in regards to Daratumumab Injection with 26 of those at Phase 3. Primarily located around Harrison, New york, there are 5,564 locations hosting studies for this particular pharmaceutical product."
Are there any openings available for individuals to partake in this medical experiment?
"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical investigation, which was initially listed online on September 22nd 2020, is currently enrolling participants. A total of 10 test subjects are needed from a single centre."
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