Status:
WITHDRAWN
Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic Cell Transplantation Recipient
Recurrent Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies the side effects and how well melphalan hydrochloride works in treating patients with multiple myeloma that has come back or does not respond to treatment. Drugs...
Detailed Description
PRIMARY OBJECTIVES: I. Identify whether targeting approximate (approx.) 3- or 5-days of severe neutropenia after exposure to a personalized melphalan hydrochloride (melphalan) dose results in best cl...
Eligibility Criteria
Inclusion
- Patient must have relapsed or refractory myeloma that fits or did fit IMWG diagnostic criteria for multiple myeloma; patients with AL amyloidosis and polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) are excluded; measurable disease is not required
- Patient undergoing autologous transplant as part of first line therapy
- All races and ethnic groups are eligible for this study
- Patients must also have an adequate autologous graft as defined as a cryopreserved peripheral blood stem cell (PBSC) graft containing \> 2 x 10\^6 CD34+ cells/kg patient weight
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \> 60%) is required for eligibility; those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible
- Absolute neutrophil count (ANC) \> 1000/uL
- Platelet count \> 50,000
- Transfusion independent
- Total bilirubin \< 1.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x the institutional upper limit of normal
- Left ventricular ejection fraction \>= 40%
- Carbon monoxide diffusing capability (DLCO) \> 50% predicted
- Forced expiratory volume in 1 second (FEV1) \> 50% predicted
- Forced vital capacity (FVC) \> 50% predicted
- Ability to understand and willingness to sign a written informed consent document
- Females of childbearing potential (FCBP) must not be pregnant as per institutional standard; if no institutional standard exists, then patients must have a negative serum or urine pregnancy test prior to transplant; a female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Exclusion
- Patients who are receiving any other anti-myeloma investigational agents
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued
- Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to \< 1 year, or confound data interpretation
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03328936
Start Date
September 1 2018
End Date
March 31 2021
Last Update
February 21 2020
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210