14
Participants
Start Date
June 1, 2023
Primary Completion Date
May 31, 2026
Study Completion Date
December 31, 2026
Daratumumab and Hyaluronidase-fihj
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection for subcutaneous use. Supplied as individually packaged single-dose vials providing 1,800 mg of daratumumab and 30,000 units of hyaluronidase per 15 mL.
Pre-Intervention Medication
"The following pre-medications will be administered 1-3 hours before each dose of DARZALEX FASPRO:~* Acetaminophen 650 to 1,000 mg orally~* Diphenhydramine 25 to 50 mg (or equivalent) orally or intravenously~* Montelukast 10mg PO prior to DARZALEX FASPRO®.~* Methylprednisolone 100 mg (or equivalent) orally or intravenously"
Post-Intervention Medication
"The following post-medications will be administered:~* Methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long acting corticosteroid) orally for 2 days starting the day after the administration of DARZALEX FASPRO®.~* Patients with a history of chronic obstructive pulmonary disease will be prescribed short and long-acting bronchodilators and inhaled corticosteroids.~* Antiviral prophylaxis for herpes zoster reactivation must be initiated within one week of daratumumab hyaluronidase-fihj administration and continued for 3 months following the end of treatment."
RECRUITING
NYU Langone Health, New York
NYU Langone Health
OTHER