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Personalized Autologous Transplant for Multiple Myeloma

NCT04483206 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-31

No results posted yet for this study

Summary

This phase I trial studies the best dose and side effects of mephalan in treating patients with multiple myeloma who are undergoing stem cell transplant. Chemotherapy drugs, such as mephalan, 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. This trial uses a new method of dosing that is based on analysis of each individual's blood levels of melphalan after receiving a part of the dose, termed pharmacokinetic analysis. This may help to learn more about how to dose melphalan correctly and which patients are likely to benefit from a personalized dose.

Conditions

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUG

Melphalan

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gateway for Cancer Research

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Craig C Hofmeister, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2026-06-30
Completion
2026-12-31
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 NCT04483206 on ClinicalTrials.gov