Multiple Myeloma Clinical Trial
Official title:
A Phase II, Open-Label, Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation
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.
OVERVIEW: This study is a single-center, open-label study of high-dose Melphalan HCl for
injection (propylene glycol free Melphalan) conducted in 24 patients, who have symptomatic
multiple myeloma and qualify for ASCT.
There will be three distinct evaluation periods in this trial: a pretreatment period, a study
period and a follow-up period.
PRETREATMENT:
Pretreatment Period Evaluations (Days -30 to -3). Baseline assessments will be collected
within 30 days of dosing with Melphalan HCl for injection (propylene glycol free), after the
patient has signed the informed consent. These include clinical and laboratory assessments
(e.g., medical history and physical examination, hematology, urine analysis, creatinine
clearance), chest X-ray and vital signs.
STUDY TREATMENT:
1. 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. Following one day of rest after the myeloablative Melphalan conditioning (day -1),
patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+
cells/kg of patient body weight (day 0).
3. Pharmacokinetic, efficacy and safety evaluations will be performed during the study
period.
FOLLOW-UP:
ASCT Day +1 until Day+100. During the follow-up period, patients will return for daily
laboratory tests (hematology and basic serum chemistry) and will be evaluated weekly by their
physicians until the engraftment date, with the final end-of-study evaluation occurring up to
seven days after engraftment date. During the follow-up period, the tests (e.g., physical
examination, CBC, vital signs, full serum chemistry panel, bone marrow biopsy) will be
performed weekly until engraftment (unless otherwise specified).
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