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

NCT02669615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-10

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Parameswaran Hari, MD, MRCP, MS · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-06-09
Completion
2017-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669615 on ClinicalTrials.gov