Personalized Autologous Transplant for Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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 criteria
Qualifiers
Patient must have the clinical diagnosis of a plasma cell neoplasm requiring treatment per the treating physician using the International Myeloma Working Group (IMWG) and World Health Organization (WHO) criteria as guidelines. This can include extraosseous plasmacytoma, monoclonal immunoglobulin deposition disease, and heavy-chain diseases as these diagnoses, while rare, can be treated in part with autologous transplant
If enrolling in phase A of this protocol, the patient
must have received 2+ lines of therapy as defined by the IMWG; and
Must have estimated glomerular filtration rate (eGFR) by Cockcroft-Gault > 40 mL/min; and
Disqualifiers
Patients known to meet criteria for progressive disease or clinical relapse between screening and planned melphalan infusion day -3
Subject has any of the following cardiac abnormalities
History of clinically significant cardiovascular disease with New York Heart Association class III or IV congestive heart failure or
Severe non-ischemic cardiomyopathy or
Trial design
Treatments tested in this trial
- Autologous Hematopoietic Stem Cell Transplantation
- Melphalan
- Questionnaire Administration
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov