Clinical trial NCT05511428: Home Based Daratumumab Administration for Patients With Multiple Myeloma
Official title: Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Plasma Cell Myeloma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2022-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 1,Baseline
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 2, Day29
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 3, Day 57
measure: Treatment satisfactionwill be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 4, Day 85
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 5, Day 113
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 6, Day 141
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 7, Day 169
measure: Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ)
timeFrame: At Visit 8, Day 197
Secondary outcomes:
measure: Medication adherence in home setting
timeFrame: At Visit 3,Day 57
measure: Medication adherence in home setting
timeFrame: At Visit 4,Day 85
measure: Medication adherence in home setting
timeFrame: At Visit 5,Day 113
measure: Medication adherence in home setting
timeFrame: At Visit 6,Day 141
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).
timeFrame: At Visit 1, Baseline
measure: Quality of life Questionnaire
timeFrame: At Visit 2, Day 29
measure: Quality of life Questionnaire
timeFrame: At Visit 3, Day 57
measure: Quality of life Questionnaire
timeFrame: At Visit 4, Day 85
measure: Quality of life Questionnaire
timeFrame: At Visit 5, Day 113
measure: Quality of life Questionnaire
timeFrame: At Visit 6, Day 141
measure: Quality of life Questionnaire
timeFrame: At Visit 7, Day 169
measure: Quality of life Questionnaire
timeFrame: At Visit 8, Day 197
measure: Financial toxicity
timeFrame: At Visit 1, Baseline
measure: Financial toxicity
timeFrame: At Visit 2, Day 29
measure: Financial toxicity
timeFrame: At Visit 3, Day 57
measure: Financial toxicity
timeFrame: At Visit 4, Day 85
measure: Financial toxicity
timeFrame: At Visit 5, Day 113
measure: Financial toxicity
timeFrame: At Visit 6, Day 141
measure: Financial toxicity
timeFrame: At Visit 7, Day 169
measure: Financial toxicity
timeFrame: At Visit 8, Day 197
measure: Incidence of adverse events
timeFrame: At Visit 2, Day 29
measure: Incidence of adverse events
timeFrame: At Visit 3, Day 57
measure: Incidence of adverse events
timeFrame: At Visit 4, Day 85
measure: Incidence of adverse events
timeFrame: At Visit 5, Day 113
measure: Incidence of adverse events
timeFrame: At Visit 6, Day 141
measure: Incidence of adverse events
timeFrame: At Visit 7, Day 169
measure: Incidence of adverse events
timeFrame: At Visit 8, Day 197
measure: Incidence of adverse events
timeFrame: At Visit 9, Day 198
measure: Barriers to home administration
timeFrame: At Visit 3, Day 57
measure: Barriers to home administration
timeFrame: At Visit 4, Day 85
measure: Barriers to home administration
timeFrame: At Visit 5, Day 113
measure: Barriers to home administration
timeFrame: At Visit 6, Day 141
Other outcomes:
measure: Patient perceptions of home based anti-neoplastic therapy
timeFrame: At Visit 3, Day 29
measure: Patient perceptions of home based anti-neoplastic therapy
timeFrame: At Visit 4, Day 57
measure: Patient perceptions of home based anti-neoplastic therapy
timeFrame: At Visit 5, Day 85
measure: Patient perceptions of home based anti-neoplastic therapy
timeFrame: At Visit 6, Day 113
measure: Opportunity cost
timeFrame: At Visit 1, Baseline
measure: Opportunity cost
timeFrame: At Visit 2, Day 29
measure: Opportunity cost
timeFrame: At Visit 3, Day 57
measure: Opportunity cost
timeFrame: At Visit 4, Day 85
measure: Opportunity cost
timeFrame: At Visit 5, Day 113
measure: Opportunity cost
timeFrame: At Visit 6, Day 141
measure: Opportunity cost
timeFrame: At Visit 7, Day 169
measure: Opportunity cost
timeFrame: At Visit 8, Day 197
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam R Binder, MD
role: PRINCIPAL_INVESTIGATOR
References: