Home Based Daratumumab Administration for Patients With Multiple Myeloma

NCT ID: NCT05511428

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2024-05-22

Brief 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.

Detailed 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.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Daratumumab and Hyaluronidase-fihj

Intervention Type: DRUG

Given SC

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Ancillary studies

Interventions

Daratumumab and Hyaluronidase-fihj

Given SC

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

DARA Co-formulated with rHuPH20; DARA/rHuPH20; Daratumumab + rHuPH20; Daratumumab with rHuPH20; Daratumumab-rHuPH20; Daratumumab/Hyaluronidase-fihj; Daratumumab/rHuPH20 Co-formulation; Darzalex Faspro; Darzalex/rHuPH20; HuMax-CD38-rHuPH20; Recombinant Human Hyaluronidase Mixed with Daratumumab; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• Able to provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged greater than 18 years of age
• Has a diagnosis of Multiple Myeloma
• Is on the monthly phase of daratumumab (either intravenous [IV] or subcutaneous [SubQ]) based regimen (every 4 weeks) (either monotherapy or in combination with oral agents)
• Is willing to receive daratumumab subcutaneous injections
• Lives within the range of Jefferson Home Infusion Services
• Patients are willing to allow home infusion company visit them and administer Darzalex-Faspro in the home
• Women of reproductive potential must use highly effective contraception
• Men of reproductive potential must use highly effective contraception
• Absolute neutrophil count (ANC) > 1,000
• Platelet count > 50,000
• Aspartate aminotransferase (AST) / alanine transaminase (ALT) < 2.5 times upper limit of normal (ULN)
• Bilirubin < 2 times ULN
• Creatinine clearance (CrCl) >= 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide >= 30 mL/min
• English speaking

Exclusion Criteria

• Receiving daratumumab for an indication other than multiple myeloma
• Receiving daratumumab in combination with other IV or subcutaneous therapy
• Pregnancy or lactation
• Known allergic reactions to components of the study product(s)
• Uncontrolled human immunodeficiency virus (HIV)
• Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) who are not on hepatitis B prophylaxis. Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive and not on Hep B prophylaxis will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV deoxyribonucleic acid (DNA) by PCR
• Patients with reactivation of hepatitis B will be excluded
• Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy)
• Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal
• Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate
• Clinically significant cardiac disease, including:

• Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)
• Uncontrolled cardiac arrhythmia
• Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Fridericia's formula > 470 msec
• Non-English Speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam R Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JT 19521

Identifier Type: OTHER

Identifier Source: secondary_id

22C.210

Identifier Type: -

Identifier Source: org_study_id