Home Based Daratumumab Administration for Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT05511428|
Recruitment Status : Recruiting
First Posted : August 23, 2022
Last Update Posted : December 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Drug: Daratumumab and Hyaluronidase-fihj Other: Questionnaire Administration Other: Quality-of-Life Assessment Other: Interview||Not Applicable|
I. Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire [CTSQ]).
I. Determine adherence to home delivery of daratumumab and hyaluronidase-fihj (darzalex faspro).
II. Evaluate quality of life (using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-30]) based on site of care (home versus [vs.] infusion center).
III. Evaluate financial burden (using the COST survey) based on site of care (home vs. infusion center).
IV. Evaluate Safety of home administration of darzalex-faspro. V. Evaluate barriers to home administration.
I. Evaluate patient perceptions of home administration of anti-neoplastic therapy.
II. Evaluate opportunity cost based on site of care (home vs. infusion center) (using the Oncology Opportunity Cost Assessment Tool [OOCAT] survey).
Patients receive daratumumab and hyaluronidase-fihj subcutaneously (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.
After completion of study treatment, patients are followed up at 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma|
|Actual Study Start Date :||November 8, 2022|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2025|
Experimental: Treatment (daratumumab and hyaluronidase-fihj)
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.
Drug: Daratumumab and Hyaluronidase-fihj
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Treatment satisfaction [ Time Frame: Up to 2 months ]Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05.
- Medication adherence in home setting [ Time Frame: Up to 2 months ]Adherence is defined as completing administration of medication in the home setting. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval.
- Quality of life [ Time Frame: Up to 2 months ]Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).
- Financial toxicity [ Time Frame: Up to 2 months ]Financial toxicity will be measured using the COST survey.
- Incidence of adverse events [ Time Frame: Up to 2 months ]Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro
- Barriers to home administration [ Time Frame: Up to 2 months ]Barriers to home administration will be measured through any delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication
- Patient perceptions of home based anti-neoplastic therapy [ Time Frame: Up to 2 months ]Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.
- Opportunity cost [ Time Frame: Up to 2 months ]Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05511428
|Contact: Adam Binder, MD||215-955-8874||Adam.firstname.lastname@example.org|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Adam Binder 215-955-7663 Adam.Binder@jefferson.edu|