Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant (NCT03328936) | Clinical Trial Compass
WithdrawnPhase 2
Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
Stopped: Sponsor decision
United States0Started 2018-09-01
Plain-language 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 used in chemotherapy, such as melphalan hydrochloride, 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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; iā¦
What they're measuring
1
Complete response proportion
Timeframe: At 90 days
Trial details
NCT IDNCT03328936
SponsorOhio State University Comprehensive Cancer Center