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Monoclonal Antibodies
Daratumumab for POEMS Syndrome
Phase 2
Waitlist Available
Led By Frits van Rhee, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 360 days
Awards & highlights
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.
Eligible Conditions
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 360 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Success
Side effects data
From 2023 Phase 2 trial • 16 Patients • NCT0407037878%
Urticaria
44%
Headache
44%
Infusion reaction; urticarial rash
22%
Difficulty breathing
22%
diarrhea
11%
Dog bite
11%
Burn on lower back
11%
Intermittent palpitations
11%
Increased agitation
11%
Supraventricular tachycardia
11%
Runny nose/itchy eyes
11%
Fall
11%
Bilateral cheek, ear, chin erythematous hives with mild swelling and itching
11%
Intermittent nausea/upset stomach
11%
COVID-19 pneumonia
11%
Insomnia
11%
UTI
11%
Vaccine reaction
11%
Elevated Liver Transaminases
11%
Repetitive sneezing
11%
Scratchy throat
11%
cough
11%
fever
11%
Floaters
11%
Increased sleepiness
11%
Overactive bladder
11%
Lower back pain/pull
11%
Brief transient unresponsiveness
11%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Daratumumab InjectionExperimental Treatment1 Intervention
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab Injection
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,289 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,517 Total Patients Enrolled
Frits van Rhee, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab Injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
POEMS Syndrome Patient Testimony for trial: Trial Name: NCT04396496 — Phase 2
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