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Monoclonal Antibodies
Home-Based Daratumumab for Multiple Myeloma
Phase < 1
Waitlist Available
Led By Adam R Binder, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is willing to receive daratumumab subcutaneous injections
Has a diagnosis of Multiple Myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at visit 9, day 198
Awards & highlights
Study Summary
This trial tests whether home-based Daratumumab administration is as effective as standard medical care in treating patients with multiple myeloma.
Who is the study for?
Adults over 18 with multiple myeloma, able to consent and follow study procedures. Must live within Jefferson Home Infusion Services range, speak English, and be on a monthly phase of daratumumab treatment. Women and men must use effective contraception. Participants need normal liver function tests, an ANC > 1,000, platelets > 50,000, and adequate kidney function.Check my eligibility
What is being tested?
The trial is testing home administration of Darzalex Faspro (daratumumab and hyaluronidase) for multiple myeloma patients. It aims to see if receiving this treatment at home can reduce costs and the burden of care compared to standard cancer center visits.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components; however specific side effects are not listed in the provided information but may align with those commonly associated with monoclonal antibodies or subcutaneous injections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to get shots of daratumumab.
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I have been diagnosed with Multiple Myeloma.
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I am using a reliable method of birth control.
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I am okay with having a home infusion company visit to give me Darzalex-Faspro.
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I am currently on a monthly daratumumab treatment, either alone or with other oral medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at visit 9, day 198
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at visit 9, day 198
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
Treatment satisfactionwill be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
Secondary outcome measures
Barriers to home administration
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).
Financial toxicity
+3 moreOther outcome measures
Opportunity cost
Patient perceptions of home based anti-neoplastic therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab and hyaluronidase-fihj)Experimental Treatment4 Interventions
Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
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Who is running the clinical trial?
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,498 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,076 Patients Enrolled for Multiple Myeloma
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,604 Total Patients Enrolled
4 Trials studying Multiple Myeloma
336 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,710 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking daratumumab for a condition that is not multiple myeloma.I am willing to get shots of daratumumab.I have been diagnosed with Multiple Myeloma.You have hepatitis C unless you have been successfully treated for it.I am using a reliable method of birth control.I am over 18 years old.Your blood platelet count is higher than 50,000.Your absolute neutrophil count is over 1,000.Your bilirubin levels are less than twice the upper limit of normal.I am currently on a monthly daratumumab treatment, either alone or with other oral medications.I am okay with having a home infusion company visit to give me Darzalex-Faspro.Your AST and ALT levels are not more than 2.5 times the upper limit of normal.I do not have serious heart conditions or recent heart attacks.I have hepatitis B but am not on prevention treatment, or I was vaccinated against it.My lung function (FEV1) is less than half of what it should be.I have had moderate to severe asthma, or uncontrolled asthma in the last 2 years.I am currently being treated with daratumumab and another therapy.I am willing and able to follow all study rules and attend all appointments.My HIV is not under control.I do not have reactivated hepatitis B.My kidney function is good enough for certain cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab and hyaluronidase-fihj)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you inform me if this research project is still recruiting individuals?
"No, this study is no longer enrolling patients. The trial was first posted on October 1st, 2022 and last updated on October 18th, 2022 according to the website clinicaltrials.gov. There are 838 other trials that are currently recruiting candidates."
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