Home Based Daratumumab Administration for Patients With Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT05511428
• Recruitment Status: Recruiting
• First Posted: August 23, 2022
• Last Update Posted: December 21, 2022
• Sponsor: Thomas Jefferson University
• Collaborator: Janssen Scientific Affairs, LLC
• Information provided by (Responsible Party): Thomas Jefferson University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plasma Cell Myeloma	Drug: Daratumumab and Hyaluronidase-fihj; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Interview	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
• Actual Study Start Date: November 8, 2022
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: January 2025

Arms and Interventions

Arm

Intervention/treatment

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.

Drug: Daratumumab and Hyaluronidase-fihj; Given SC; Other 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; Other: Questionnaire Administration; Ancillary studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Interview; Ancillary studies

Outcome Measures

Primary Outcome Measures :

1. Treatment satisfaction [ Time Frame: Up to 2 months ]
   Treatment satisfaction will be measured using the Cancer Treatment Satisfaction Questionnaire (CTSQ). The mean difference in CTSQ scores between home and infusion center will be computed with the corresponding 95% confidence interval and tested (null hypothesis of zero mean difference) using appropriate model-based contrast with alpha 0.05.

Secondary Outcome Measures :

1. Medication adherence in home setting [ Time Frame: Up to 2 months ]
   Adherence is defined as completing administration of medication in the home setting. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center). The model will be used to compute the average rate of home setting adherence with the corresponding 95% confidence interval.
2. Quality of life [ Time Frame: Up to 2 months ]
   Measurement of quality of life will be measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).
3. Financial toxicity [ Time Frame: Up to 2 months ]
   Financial toxicity will be measured using the COST survey.
4. Incidence of adverse events [ Time Frame: Up to 2 months ]
   Safety will be evaluated through collection of adverse events, administration reactions related to Darzalex-Faspro
5. Barriers to home administration [ Time Frame: Up to 2 months ]
   Barriers to home administration will be measured through any delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication

Other Outcome Measures:

1. Patient perceptions of home based anti-neoplastic therapy [ Time Frame: Up to 2 months ]
   Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.
2. Opportunity cost [ Time Frame: Up to 2 months ]
   Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Adam Binder, MD; 215-955-8874; Adam.binder@jefferson.edu

Locations

United States, Pennsylvania

Sidney Kimmel Cancer Center at Thomas Jefferson University; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: Adam Binder 215-955-7663 Adam.Binder@jefferson.edu

Sponsors and Collaborators

Thomas Jefferson University

Janssen Scientific Affairs, LLC

More Information

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT05511428
• Other Study ID Numbers: 22C.210
• First Posted: August 23, 2022
• Last Update Posted: December 21, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Daratumumab; Antibodies, Monoclonal; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs