Home Based Daratumumab Administration for Patients With Multiple Myeloma

This is an interventional treatment trial for Plasma Cell Myeloma Read More

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