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Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma

NCT05013437 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-04-02

No results posted yet for this study

Summary

The purpose of this study is to see if Multiple Myeloma (MM) cells are sensitive to the chemotherapy used in transplant or not. The main chemotherapy agent utilized in stem cell transplant is melphalan. The study will utilize 1/10 of the dose used in transplant to study sensitivity of the tumor to melphalan. Melphalan is approved by the U.S. Food and Drug Administration (FDA) for transplant for MM patients.

Conditions

Interventions

DRUG

Evomela

16 mg/m\^2 Evomela administered one time via a central line

DEVICE

Next Generation Sequencing

Next Generation Sequencing

DRUG

Prochlorperazine

10mg once intravenous (IV) within 30 minutes before Evomela

DRUG

Acetaminophen

650 mg once orally within 30 minutes before Evomela

DRUG

Diphenhydramine

50 mg once intravenously within 30 minutes before Evomela

Sponsors & Collaborators

  • Koen van Besien

    lead OTHER

Principal Investigators

  • Koen van Besien, MD, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-12-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT05013437 on ClinicalTrials.gov