A Phase 2 interventional study of Palonosetron in Multiple Myeloma, sponsored by Eisai Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.
Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment
The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.
A number of multiple-day chemotherapy regimens involving moderately or highly emetogenic agents are used for the treatment of cancers. Further, patients undergoing high-dose conditioning regimens in combination with bone marrow or stem cell transplants remain poorly controlled in terms of CINV. Patients treated with these regimens are at risk for developing CINV with each treatment as well as in the delayed setting.
Palonosetron to date, has been studied against single-day moderately and highly emetogenic chemotherapy regimens. It is of interest, therefore, to explore the safety and efficacy of palonosetron when administered during a multiple-day chemotherapy regimen. For this purpose, a population receiving melphalan (100 mg/m\^2) as a conditioning regimen before stem cell transplant for the treatment of multiple myeloma was selected.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 75 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on Study Day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:
Note: with the exception of first-generation 5-HT3-receptor antagonists, above medication(s) may be used as rescue medication.
Drug: Palonosetron
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Eisai Inc.