home based daratumumab administration for patients with multiple myeloma

Conditions: Plasma Cell Myeloma

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.

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.

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