RecruitingPhase 1NCT04483206

Personalized Autologous Transplant for Multiple Myeloma

Phase 1 of Exposure Targeted Melphalan Dosing


Sponsor

Emory University

Enrollment

90 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests personalized approaches to stem cell transplants (using the patient's own stem cells) for people with multiple myeloma — a cancer of plasma cells in the bone marrow. It aims to tailor the high-dose chemotherapy dose based on individual patient factors to improve safety and outcomes. **You may be eligible if...** - You have been diagnosed with multiple myeloma or a related plasma cell disorder that requires treatment - You have received at least 2 prior lines of therapy - Your kidney function meets the minimum required level - Your doctor has determined you are a candidate for an autologous (your own cells) stem cell transplant **You may NOT be eligible if...** - You have not yet received prior treatment - Your kidney function is too low to safely receive high-dose chemotherapy - You have other conditions that make transplant unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUGMelphalan

Given IV

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

University Illinois Chicago

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT04483206


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