Home Based Daratumumab Administration for Patients With Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05511428
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Thomas Jefferson University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Myeloma
Additional Details

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 & Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Adam Binder

Adam.Binder@jefferson.edu

215-955-7663