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Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan

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ClinicalTrials.gov Identifier: NCT02939287
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:

The purpose of this study is to help answer the following research question:

  • Whether administration of an aprepitant containing regimen, an olanzapine containing regimen or regimen containing both will prevent nausea and vomiting better for patients undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these medications are approved by the United States Food and Drug Administration (FDA) for nausea and vomiting.
  • Participants will be randomly assigned to one of the 3 treatment groups:

    • Arm A: aprepitant containing anti-emetic therapy
    • Arm B: olanzapine containing anti-emetic therapy
    • Arm C: Aprepitant plus olanzapine containing anti-emetic therapy

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Aprepitant Drug: Olanzapine Drug: Aprepitant plus Olanzapine Phase 3

Detailed Description:

This is a multi-center, randomized, non-inferiority phase 3 study conducted to determine an appropriate anti-emetic regimen for patients receiving melphalan for an autologous stem cell transplant (SCT). Candidates for this trial will include patients aged 18-80 years with hematologic malignancies receiving high dose melphalan as part of a conditioning regimen for an autologous stem cell transplant. Patients will be enrolled in 3 arms. Patients in Arm A will receive an aprepitant containing anti-emetic regimen. Patients in Arm B will receive an olanzapine containing anti-emetic regimen. Patients in Arm C will receive an aprepitant plus olanzapine containing anti-emetic regimen. Patients must be able to tolerate oral medications.

Patients will be carefully monitored for rates of emesis, nausea, and mucositis. Any adverse events will be recorded. Impact on quality of life will also be assessed. A total of 184 patients will be accrued to each arm. It is anticipated that the accrual period will last approximately 2-3 years. The primary endpoint of this study is a complete response, defined as no emesis and no rescue therapy within 120 hours of melphalan administration.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Aprepitant- and Olanzapine- Containing Regimens for Prevention of Acute and Delayed Nausea and Vomiting Associated With High Dose Melphalan and BEAM in Autologous Stem Cell Transplant Patients
Actual Study Start Date : September 23, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aprepitant
aprepitant plus standard anti-emetic regimen
Drug: Aprepitant
Add aprepitant to anti-emetic regimen
Other Name: Emend

Experimental: Olanzapine
olanzapine plus standard anti-emetic regimen
Drug: Olanzapine
add olanzapine to anti-emetic regimen
Other Name: Zyprexa

Experimental: Aprepitant plus olanzapine
aprepitant and olanzapine plus standard anti-emetic regimen
Drug: Aprepitant plus Olanzapine
add aprepitant and olanzapine to anti-emetic regimen
Other Names:
  • Emend
  • Zyprexa




Primary Outcome Measures :
  1. complete response (CR) [ Time Frame: within 120 hours following melphalan administration ]
    no emesis and no rescue anti-emetic therapy


Secondary Outcome Measures :
  1. Acute complete response [ Time Frame: 0 to 24 hours ]
    no emesis or rescue therapy

  2. Delayed complete response [ Time Frame: 25-120 hours ]
    no emesis or rescue therapy

  3. Very delayed complete response [ Time Frame: 121-168 hours ]
    no emesis or rescue therapy

  4. Mucositis/Significant mucositis [ Time Frame: up to 14 days ]
  5. Time to neutrophil engraftment [ Time Frame: up to 14 days ]
  6. Time to platelet engraftment [ Time Frame: up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autologous transplant containing high dose melphalan as part of the conditioning regimen (single or 2 day melphalan; BEAM [carmustine, etoposide, cytarabine, melphalan])
  • able to tolerate oral medications

Exclusion Criteria:

  • Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy
  • Any anti-emetic treatment within 24 hours before planned high dose conditioning chemotherapy
  • Pregnancy
  • Baseline corrected QT interval (QTc) > 500 ms
  • History of seizures
  • History of central nervous system (CNS) disease
  • Human immunodeficiency virus (HIV)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939287


Contacts
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Contact: Kathryn Schultz, PharmD 3129472405 kathryn_schultz@rush.edu
Contact: Sunita Nathan, MD 312-942-1424 sunita_nathan@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kathryn Schultz, PharmD    312-947-2405    kathryn_schultz@rush.edu   
Contact: Sunita Nathan, MD    312-942-1424    sunita_nathan@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Kathryn Schultz, PharmD Rush University Medical Center

Publications:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02939287     History of Changes
Other Study ID Numbers: 14102001
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Rush University Medical Center:
autologous
myeloma
transplant

Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Melphalan
Olanzapine
Aprepitant
Fosaprepitant
Antiemetics
Emetics
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents