Multi-day Doses in Prevention of Nausea and Emesis

NCT00600353 | Completed Phase 2 Results DMC

• 1 other identifier: 10862
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

Conditions

Myeloma, Plasma-Cell; Lymphoma, Malignant

Keywords

nausea; cancer; CINV

Outcome Measures

Primary Outcomes (4)

• Overall Emetic Response: Acute

  Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.

  24 hours after chemotherapy

• Overall Emetic Response: Delayed

  Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.

  24 to 72 hours after chemotherapy

• Overall Emetic Response: Extended

  Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.

  72 hours after chemotherapy

• Overall Emetic Response

  Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.

  At leaset 24 hours to more than 72 hours after chemotherapy

Secondary Outcomes (1)

• Impact of Nausea and Vomiting on the Quality of Life of Patients Undergoing Autologous HSCT

  24 hours, Day 3, Day 7

Study Arms (1)

Melphalan, dexamethasone, aprepitant, palonosetron

EXPERIMENTAL

Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant

Drug: Palonosetron; Drug: Aprepitant; Drug: Dexamethasone

Interventions

Palonosetron DRUG

Palonosetron 0.25 mg IV over 30 seconds

Also known as: Aloxi

Melphalan, dexamethasone, aprepitant, palonosetron

Aprepitant DRUG

Aprepitant 125 mg PO and Aprepitant 80 mg PO

Also known as: Emend

Melphalan, dexamethasone, aprepitant, palonosetron

Dexamethasone DRUG

Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push

Also known as: Decadron

Melphalan, dexamethasone, aprepitant, palonosetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma and lymphoma deemed by the treating institution to be candidates for high dose chemotherapy and autologous hematopoietic stem cell transplant.
• Both males and females are eligible.
• Patients should be 18 years old; multiple myeloma patients up to age 75 and lymphoma patients up to age 65 are eligible.
• Patients with Karnofsky performance status of 60% or better.
• Patients should have at least 2.5 x 106 cyropreserved CD34+ cells per kilogram available for transplantation.
• Patients with adequate bone marrow function as defined as ANC ≥1000 cells/mm3 , platelet ≥ 75,000 cells/mm3.
• Lymphoma patient must have adequate renal function as defined by a calculated creatinine clearance of 50% measured in ml/min.
• The criteria for renal function does not apply for multiple myeloma patients. Multiple myeloma patients undergoing hemodialysis are eligible.
• All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater or equal to 48% within 42 days prior to registration.
• Patients must have adequate pulmonary function as defined by room air pulse oximetry equal to or greater than 93%, and pulmonary function tests (FEV1 and DLCO) equal to or greater than 50% of predicted values.
• Patients with adequate hepatic function as defined by serum bilirubin lower than 2.5 mg/dL and liver function tests to not exceed greater than 1.5x of the institutions ULN.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with the institutional and federal guidelines.
• Patients must be able to complete the anti-emesis assessment questionnaire. A Spanish questionnaire will be available for Hispanic-speaking patients.

You may not qualify if:

• Patients with nausea and have emetic episodes, and are receiving any anti-emetic medication taken within 24 hours of receiving antibiotics.
• Active infection involving intravenous antibiotics.
• Patients with known active hepatitis B and/or hepatitis C infections are excluded.
• Patients with known HIV infection.
• Primary or secondary brain neoplasms with increased intracranial pressure.
• Received intrathecal chemotherapy within 24 hours of first dose of conditioning chemotherapy.
• Patients who are nursing mothers or pregnant. Females of childbearing age are required to have a negative serum B-HCG pregnancy test 24 hours prior to enrollment on the study.
• Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years.
• Patients with uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary heart disease, arrhythmias), pulmonary hepatic and renal disease unless renal insufficiency is felt to be secondary to multiple myeloma,
• Myocardial infarction within 6 months of enrollment in the study.
• Major surgery within 4 weeks of enrollment.
• Morbid obesity (BMI\>40)
• Patients with psychiatric or central nervous systems disorders interfering with ability to comply with study protocol.
• Patients receiving therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoaguable states. Coumadin at 1 mg as prophylaxis for central venous catheter is allowed.
• Known hypersensitivity to 5-HT3 antagonists and Aprepitant and their components.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Nausea; Neoplasms

Interventions

Palonosetron; Aprepitant; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Omar Aljitawi
• Organization: University of Kansas Medical Center

oaljitawi@kumc.edu

913-588-6029

Study Officials

• Omar Aljitawi, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 25, 2008
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

US (1)