Home Based Daratumumab Administration for Patients With Multiple Myeloma

Trial Title: Home Based Daratumumab Administration for Patients With Multiple Myeloma

NCT ID: NCT05511428

Condition: Plasma Cell Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Daratumumab
Antibodies, Monoclonal

Study type: Interventional

Study phase: Early Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Daratumumab and Hyaluronidase-fihj
Description: Given SC
Arm group label: Treatment (daratumumab and hyaluronidase-fihj)

Other name: DARA Co-formulated with rHuPH20

Other name: DARA/rHuPH20

Other name: Daratumumab + rHuPH20

Other name: Daratumumab with rHuPH20

Other name: Daratumumab-rHuPH20

Other name: Daratumumab/Hyaluronidase-fihj

Other name: Daratumumab/rHuPH20 Co-formulation

Other name: Darzalex Faspro

Other name: Darzalex/rHuPH20

Other name: HuMax-CD38-rHuPH20

Other name: Recombinant Human Hyaluronidase Mixed with Daratumumab

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Treatment (daratumumab and hyaluronidase-fihj)

Intervention type: Other
Intervention name: Quality-of-Life Assessment
Description: Ancillary studies
Arm group label: Treatment (daratumumab and hyaluronidase-fihj)

Other name: Quality of Life Assessment

Intervention type: Other
Intervention name: Interview
Description: Ancillary studies
Arm group label: Treatment (daratumumab and hyaluronidase-fihj)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sidney Kimmel Cancer Center at Thomas Jefferson University

Address:
City: Philadelphia
Zip: 19107
Country: United States

Start date: November 8, 2022

Completion date: November 8, 2025

Lead sponsor:
Agency: Thomas Jefferson University
Agency class: Other

Collaborator:
Agency: Janssen Scientific Affairs, LLC
Agency class: Industry

Source: Thomas Jefferson University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05511428