Home Based Daratumumab Administration for Patients With Multiple Myeloma

Status Active, not recruiting

Clinical Trial Summary

This clinical trial tests the treatment effect of home based daratumumab administration in treating patients with multiple myeloma. Darzalex Faspro is a combination of two drugs (daratumumab and hyaluronidase) used to treat adults with multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Standard medical care requires Darzalex-Faspro treatment be administered during visits to the cancer center. Receiving medication in the home setting, may decrease cost and burden of care in patients with multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire [CTSQ]). SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: 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). OUTLINE: 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05511428
Study type	Interventional
Source	Thomas Jefferson University
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	November 8, 2022
Completion date	November 8, 2025

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Completed	`NCT02513186` - Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation	Phase 1
Recruiting	`NCT04977024` - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer	Phase 2
Recruiting	`NCT05497804` - Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial	Phase 2
Completed	`NCT02880228` - Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant	Phase 2
Recruiting	`NCT04782687` - Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma	Phase 2
Completed	`NCT02514668` - A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma	Phase 1
Active, not recruiting	`NCT03417284` - Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation	Phase 1/Phase 2
Active, not recruiting	`NCT05142371` - Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors	N/A
Terminated	`NCT03272633` - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies	Early Phase 1
Recruiting	`NCT05031897` - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant	Phase 2
Active, not recruiting	`NCT03275285` - Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients	Phase 3
Completed	`NCT04100044` - Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma	N/A
Active, not recruiting	`NCT00075478` - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer	Phase 3
Recruiting	`NCT05561387` - Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment	Phase 3
Completed	`NCT03317899` - Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma	Phase 2
Active, not recruiting	`NCT01919619` - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies	Phase 2
Terminated	`NCT02353572` - Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma	Phase 1/Phase 2
Recruiting	`NCT04537871` - Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Active, not recruiting	`NCT00719888` - Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease	Phase 2