A Phase 2 Open Label Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma
Primary objective: To determine the incidence of infusion related reactions (IRR's) in the first 6 months of daratumumab administration.
Primary Outcome:
Study Design: This is an open label phase II study of a daratumumab accelerated infusion regimen and a fixed pre- and post-medication regimen, in patients with relapsed and refractory Multiple Myeloma. Patients will receive daratumumab, in the following schedule: Daratumumab 8mg/kg in 500 mL over 4 hours Cycle 1 Day 1, Daratumumab 16mg/kg in 500 mL over 90 minutes (20% of dose given in first 30 minutes and remaining 80% of dose given over 60 minutes) Cycle 1 Days 8, 15 and 22; Cycle 2 Days 1, 8, 15, and 22 and on Days 1 and 15 for Cycles 3-6, and Day 1 of each cycle for Cycle 7 and beyond for each 28-day cycle. The study will begin with a 6-patient lead-in phase where safety with regards to the number of Grade 4 infusion related reactions with the accelerated infusion protocol will be evaluated in real time. Accrual to the study will not stop during this evaluation. The safety information obtained will be reviewed and evaluated in the context of previously published data. The review will be conducted by a 3-physician panel and if serious safety concerns (defined as Grade 4 infusion related reactions and/or death) are identified, the panel will make recommendations about protocol modifications if deemed necessary. Pre- and post-medication regimen: Montelukast 10 mg po x 2 days prior to daratumumab administration and 10 mg po the morning of daratumumab administration. Cetirizine 10 mg po x 2 days prior to daratumumab administration and 10 mg po the morning of daratumumab administration. Dexamethasone 20mg on days of and day following daratumumab administration. Acetaminophen 1g po 1 hour prior to daratumumab administration. Diphenhyramine 50mg IV 1 hour prior to daratumumab infusion. Individual subjects will remain on treatment as long as there is no evidence of disease progression or unacceptable toxicity or until a patient/physician decision to discontinue is made. Disease assessments as determined by the Site Investigator will be made according to the IMWG response criteria guidelines for MM.1 As this study is designed to evaluate the IRRs associated with a shortened infusion time of daratumumab administration over a 6-month time period, subjects will be followed on study for a maximum of 6 months following enrollment. Following this time period, all subjects who continue to have a response to daratumumab will be taken off study. Although the study may end before subjects progress from their disease, daratumumab treatment will continue until disease progression in the absence of uncontrolled side effects or voluntary discontinuation of treatment for any reason, although drug will be supplied outside of the clinical trial setting.
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