Randomised, Placebo Controlled, Single-center, Double-blind Clinical Trial to Investigate Efficacy and Safety of Aprepitant Combined With Kevatril and Dexamethasone Versus Placebo Combined With Kevatril and Dexamethasone in Prevention of Acute and Delayed High-dose Chemotherapy-induced Nausea and Vomiting in Subjects With Multiple Myeloma Receiving an Autologous Peripheral Blood Stemcell Transplantation.
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Randomised, Placebo Controlled, Single-center, Double-blind Clinical Trial to Investigate Efficacy and Safety of Aprepitant Combined With Kevatril and Dexamethasone Versus Placebo Combined With Kevatril and Dexamethasone in Prevention of Acute and Delayed High-dose Chemotherapy-induced Nausea and Vomiting in Subjects With Multiple Myeloma Receiving an Autologous Peripheral Blood Stemcell Transplantation.
Inclusion Criteria:
- Men and women >/= 18 years
- Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and
autologous peripheral stemcell transplantation
- Signed informed consent
Exclusion Criteria:
- Patients suffering from nausea and vomiting during the last 12 hours prior to planned
high-dose chemotherapy
- Patients receiving antiemetics 24 hours prior to planned high-dose chemotherapy
- Intake of steroids
- History of hypersensitivity to the investigational product or to any drug with
similar chemical structure or to any excipient present in the pharmaceutical form of
the investigational product
- Simultaneous intake of pimozide, terfenadine, astemizole
- Pregnant or nursing woman
- Mental condition rendering the subject incapable to understand the nature, scope and
possible consequences of the trial
- Expected non-compliance in completing the subject´s diary and FLIE-score
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall complete response (no emesis and no rescue therapy)
Outcome Time Frame:
During and post chemotherapy (0-120 h)
Safety Issue:
No
Principal Investigator
Gerlinde Egerer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Heidelberg; Im Neuenheimer Feld 410; 69120 Heidelberg/ Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
EmNa (2001-004956-38)
NCT ID:
NCT00571168
Start Date:
July 2005
Completion Date:
December 2010
Related Keywords:
- Multiple Myeloma
- chemotherapy induced nausea and vomiting
- autologous peripheral blood stemcell transplantation
- high dose chemotherapy
- Multiple Myeloma
- Neoplasms, Plasma Cell
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