Home Based Daratumumab Administration for Patients With Multiple Myeloma

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 20 patients (estimated)

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Sidney Kimmel Cancer Center Thomas Jefferson University

Philadelphia, PA

Open and Accepting
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