NCT02669615

Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

A Phase II, Open-Label, Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Melphalan HCl for injection (propylene glycol free)	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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-09
• Completion: 2017-07-19
• First posted: 2016-02-01
• Last updated: 2018-10-10
• Results posted: 2018-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study