Multiple Myeloma Clinical Trial

Home Based Daratumumab Administration for Patients With Multiple 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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

20

Study ID:

NCT05511428

Recruitment Status:

Not yet recruiting

Sponsor:

Thomas Jefferson University

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There is 1 Location for this study

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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Adam Binder
Contact
215-955-7663
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

20

Study ID:

NCT05511428

Recruitment Status:

Not yet recruiting

Sponsor:


Thomas Jefferson University

How clear is this clinincal trial information?

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