Actively Recruiting
Personalized Autologous Transplant for Multiple Myeloma
Led by Emory University · Updated on 2025-05-31
90
Participants Needed
2
Research Sites
293 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Personalized Autologous Transplant for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of a plasma cell neoplasm requiring treatment per physician using IMWG and WHO guidelines, including rare related diseases
- For phase A enrollment: must have received at least 2 prior lines of therapy and have estimated glomerular filtration rate (eGFR) > 40 mL/min and be eligible for 200 mg/m2 melphalan
- For phase B enrollment: transplant must be part of first line therapy
- Absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000
- Total bilirubin < 1.5 x institutional upper limit of normal or < 3 mg/dL if diagnosed with Gilbert's syndrome
- AST and ALT < 3 x institutional upper limit of normal
- Left ventricular ejection fraction >= 45%
- Lung function (DLCO, FEV1, FVC) > 50% of predicted (corrected for hemoglobin)
- ECOG performance status <= 2 (Karnofsky >= 60%) with allowance for bone pain related to multiple myeloma
- Females of childbearing potential must have negative pregnancy test and agree to use contraception; men must agree to use contraception during and 3 months after study
- Willing to comply with fertility requirements
- Ability to understand and sign informed consent
- Patients with prior or concurrent malignancy without interference with safety or efficacy assessment are eligible
You will not qualify if you...
- Progressive disease or clinical relapse between screening and planned melphalan infusion on day -3
- History of severe heart conditions including NYHA class III or IV heart failure, recent myocardial infarction within 6 months, severe cardiomyopathy, unstable angina, uncontrolled hypertension, significant arrhythmias, or ECG abnormalities including QTc > 480 msec
- HIV positive unless controlled with CD4 > 350, undetectable viral load, and on non-interacting therapy
- Hepatitis B surface antigen positive unless resolved infection with negative HBV DNA PCR
- Hepatitis C positive unless sustained virologic response with no viremia for at least 12 weeks
- Diagnosis of POEMS syndrome, amyloid light-chain amyloidosis, or Waldenstrom macroglobulinemia
- Active medical conditions or infections that may interfere with study or pose hazard
- Known inability to comply with study protocol due to substance abuse, psychological disorder, or other conditions
- Pregnant or breastfeeding women due to potential risks to fetus or infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University Illinois Chicago
Chicago, Illinois, United States, 60607
Not Yet Recruiting
Research Team
C
Craig Hofmeister, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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