Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Vomiting; Nausea

Treatments: Drug: Ondansetron; Drug: Dexamethasone; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT00314743

03-1192

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients 18 years of age or older
• Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
• Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
• Written informed consent

Exclusion criteria

• Nausea at baseline
• Chronic use of other antiemetic agent(s)
• Gastrointestinal obstruction or active peptic ulcer
• Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
• Allogeneic stem cell transplant recipient
• Aspartate transaminase (AST) > 3x upper limit of normal (ULN)
• Alanine transaminase (ALT) > 3x ULN
• Bilirubin > 3x ULN
• Alkaline phosphatase > 3x ULN
• Creatinine > 2
• Documented hypersensitivity to any component of study regimen
• Pregnant or lactating women
• Participating in a clinical trial which involves other investigational agent(s)
• Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Control (No aprepitant)

Active Comparator group

Description:

Regimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 20 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 20 mg IV)

Treatment:

Drug: Dexamethasone

Drug: Ondansetron

Experimental (with aprepitant)

Experimental group

Description:

Aprepitant 125 mg PO will be given 30 minutes prior to the first dose of chemotherapy followed by Aprepitant 80 mg PO QD for the remainder of chemotherapy and continuing for a total of 2 days after completing the regimen. Regimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 10 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 10 mg IV)

Treatment:

Drug: Aprepitant

Drug: Dexamethasone

Drug: Ondansetron