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Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant

NCT03328936 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-02-21

No results posted yet for this study

Summary

This randomized phase II trial studies the side effects and how well melphalan hydrochloride works in treating patients with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as melphalan hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

  • Hematopoietic Cell Transplantation Recipient
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan Hydrochloride

Given personalized dose IV for predicted 3-day duration of severe neutropenia

DRUG

Melphalan Hydrochloride

Given personalized dose IV for predicted 5-day duration of severe neutropenia

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Ashley Rosko, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03328936 on ClinicalTrials.gov