Clinical Trial Finder

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

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.#46; 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.#46; 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.

Arms

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.

Interventions

Drug: - Daratumumab and Hyaluronidase-fihj

Given SC

Other: - Questionnaire Administration

Ancillary studies

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Interview

Ancillary studies