At a glance
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A Phase II, Open-Label, Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation
In Brief
A Phase 2 clinical trial evaluating Melphalan HCl for injection (propylene glycol free) for Multiple Myeloma. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study is a single-center, open-label study of high-dose Melphalan HCl (hydrochloric acid) for injection (propylene glycol-free Melphalan) conducted in 24 patients, who have symptomatic multiple myeloma and qualify for autologous stem-cell transplantation (ASCT). There will be three distinct evaluation periods in this trial: a pretreatment period, a study period and a follow-up period.
Study Details
Timeline
Interventions
During the study period, patients will receive 200 mg/m\^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.