Personalized Autologous Transplant for Multiple Myeloma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04483206
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo ASCT
  • Melphalan — DRUG
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
May 20, 2021
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Melphalan-based autologous transplant)
    Patients receive high dose (100 mg/m2) melphalan IV over 30 minutes on day -3 and PK-directed melphalan IV over 30 minutes on day -1 to achieve set cumulative melphalan exposure levels. Patients then undergo stem cell infusion on day 0.

Primary Outcome Measure

Predicted versus observed total melphalan area under the curve (AUC) [ Time Frame: At Days -3 and -1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Loizos C. Nikolaou
[email protected]
404-778-8658
Craig C Hofmeister, MD, MPH (PRINCIPAL_INVESTIGATOR)
University Illinois ChicagoChicagoIllinois60607
Karen Sweiss, PharmD
[email protected]
312-996-0875

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Winship Cancer Institute of Emory University· Atlanta, GAUniversity Illinois Chicago· Chicago, IL

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