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Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients

NCT02994784 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-05-24

Study results available
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Summary

This is a single arm, open label study designed to evaluate the safety and efficacy of propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment will be comprised of propylene glycol-free melphalan hydrochloride administered intravenously at a dose of 70-100 mg/m2/day on Days -3 and -2 as conditioning prior to autologous stem cell transplantation.

Conditions

  • Amyloidosis; Systemic

Interventions

DRUG

Propylene Glycol-Free Melphalan Hydrochloride

Intravenous Propylene Glycol-Free Melphalan Hydrochloride

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • John M Sloan, MD · Attending Physician

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2022-07-01
Completion
2022-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02994784 on ClinicalTrials.gov