Myeloma, Plasma-CellPhase 2NCT00600353
Multi-day Doses in Prevention of Nausea and Emesis
A Phase 2 study testing Palonosetron, Aprepitant and Dexamethasone in people with Myeloma, Plasma-Cell and Lymphoma, Malignant, run by University of Kansas Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Plasma-Cell, Lymphoma, Malignant
- What is being tested?
- Palonosetron, Aprepitant and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Use of non-prescription and herbal-type medications within 72 hours of enrollment on the study. Their use are not allowed during the study. Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Combined Use of Multi-Day Doses of Palonosetron and Aprepitant With Low Doses Dexamethasone in Prevention of Nausea and Emesis Among Patients With Multiple Myeloma and Lymphoma Undergoing Autologous Stem Cell Transplant: A Pilot Study
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).
Read the detailed description
The use of high doses of chemotherapy and autologous stem cell transplant has been shown to prolong disease control among patients with multiple myeloma and patients with lymphomas that have relapsed or recurred. Patients who receive autologous stem cell transplants have their own stem cells collected and stored prior to receiving high-dose chemotherapy, the stem cells are then given back to the patient as a transplant. However, the use of high doses of chemotherapy is associated with significant side effects of nausea and vomiting. Before the use of newer medications, the incidence of nausea and vomiting could be as high as 70-90%.
Nausea is an unpleasant feeling and awareness of the urge to vomit. Vomiting is the process of throwing up forcefully the contents of the stomach. Retching is an act similar to vomiting but do not produce throwing up of the contents of the stomach. It is also called "dry heaves".
There are three kinds of nausea and vomiting associated with chemotherapy. Acute nausea and/or vomiting occur within the first 24 hours after administration of chemotherapy. Delayed nausea and/or vomiting begins after the first 24 hours of chemotherapy and could last for several days afterwards. Anticipatory nausea/vomiting is experienced prior to administration of the subsequent chemotherapy.
Chemotherapy produces nausea and vomiting by damaging the cells lining the stomach and intestines which results in the release a substance called serotonin. The serotonin binds to a protein or "receptor" (5-HT3 receptor) in the lining of the intestines. The receptors then send a message to the vomiting center in the brain. The brain then sends signals to the body to produce nausea and vomiting.
Another substance, called substance P, is also released from the lining of the stomach and intestines with damage by chemotherapy, and is released together with serotonin. The substance P binds to another protein called "neurokinin-1 receptor" or NK-1 receptor. These proteins are found in the intestines and another portion of the brain called "tractus solitarius". The brain then signals the body to produce nausea and vomiting.
The stimulation of the serotonin proteins results in acute nausea and vomiting. The stimulation of the NK-1 protein results in delayed nausea and vomiting.
There are medications that could block the serotonin and NK-1 proteins. Serotonin blockers such as ondansetron or Zofran® are now considered the medications of choice to prevent and treat nausea and vomiting in the transplant setting. However, their use could still result in nausea and vomiting in up to 40-50% of patients.
Nausea and vomiting negatively impacts the quality of life of patients undergoing stem cell transplant for their multiple myeloma and lymphoma. It can affect their appetite and sleep; and can interfere with activity, social life and enjoyment of life. Therefore, it is important to find better ways to prevent and control nausea and vomiting associated with chemotherapy.
There are two new medications that are available for patients who receive regular doses of chemotherapy. One is the long acting preparation of the serotonin blocker called palonosetron or Aloxi®. It is used to control both acute and delayed nausea and vomiting. Another medication could block the NK-1 receptor, and is called aprepitant or Emend®. This prevents delayed nausea and vomiting.
Although these two medications are tested and proven to be effective among patients who receive regular doses of chemotherapy, they have not been tested in combination among patients who undergo high doses of chemotherapy in the setting of autologous stem cell transplant.
The purpose of this study is to evaluate if the combination of these two medications, together with small doses of steroids (dexamethasone), would be effective in preventing both acute and delayed vomiting associated with high doses of chemotherapy and stem cell transplant for patients with multiple myeloma and lymphoma. The usual way to administer palonosetron is by single injection in the vein before chemotherapy. This is shown to be effective for chemotherapy given for 1 day. Since chemotherapy regimen for transplant requires multiple days of treatment, palonosetron will also be administered on multiple days thereby delivering higher doses of this drug. Aprepitant would be administered at standard doses. This study would assess if combining palonosetron and aprepitant as well as giving multiple and higher doses of palonosetron would be safe and effective in the control of nausea and vomiting in the setting of transplant. The study would evaluate the effect of combined palonosetron and aprepitant on the quality of life with regards to nausea and vomiting, of patients undergoing transplant.
- Conditions
- Myeloma, Plasma-Cell, Lymphoma, Malignant
- Being tested
- Palonosetron, Aprepitant, Dexamethasone
- Keywords
- nausea, cancer, CINV
- Medical subject headings
- Multiple Myeloma, Lymphoma, Nausea, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called Aloxi
Palonosetron 0.25 mg IV over 30 seconds
AprepitantDrug
Also called Emend
Aprepitant 125 mg PO and Aprepitant 80 mg PO
DexamethasoneDrug
Also called Decadron
Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Palonosetron; Drug: Aprepitant; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
To determine quality of life, subjects' responses to the modified Osoba modules were converted to a 0 - 100 scale, with higher scores indicative of better QOL
Measured: 24 hours, Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myeloma, Plasma-CellStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Omar Aljitawi, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600353
- Sponsor's protocol ID
- 10862
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2008
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Multi-Day Doses of Palonosetron and Aprepitant With Low Doses Dexamethasone in Prevention of Nausea and Emesis Among Patients With Multiple Myeloma and Lymphoma Undergoing Autologous Stem Cell Transplant: A Pilot Study
- ClinicalTrials.gov ID
- NCT00600353
- Acronym / sponsor ID
- 10862
- Conditions
- Myeloma, Plasma-Cell, Lymphoma, Malignant
- Keywords
- nausea, cancer, CINV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The use of high doses of chemotherapy and autologous stem cell transplant has been shown to prolong disease control among patients with multiple myeloma and patients with lymphomas that have relapsed or recurred. Patients who receive autologous stem cell transplants have their own stem cells collected and stored prior to receiving high-dose chemotherapy, the stem cells are then given back to the patient as a transplant. However, the use of high doses of chemotherapy is associated with significant side effects of nausea and vomiting. Before the use of newer medications, the incidence of nausea and vomiting could be as high as 70-90%.
Nausea is an unpleasant feeling and awareness of the urge to vomit. Vomiting is the process of throwing up forcefully the contents of the stomach. Retching is an act similar to vomiting but do not produce throwing up of the contents of the stomach. It is also called "dry heaves".
There are three kinds of nausea and vomiting associated with chemotherapy. Acute nausea and/or vomiting occur within the first 24 hours after administration of chemotherapy. Delayed nausea and/or vomiting begins after the first 24 hours of chemotherapy and could last for several days afterwards. Anticipatory nausea/vomiting is experienced prior to administration of the subsequent chemotherapy.
Chemotherapy produces nausea and vomiting by damaging the cells lining the stomach and intestines which results in the release a substance called serotonin. The serotonin binds to a protein or "receptor" (5-HT3 receptor) in the lining of the intestines. The receptors then send a message to the vomiting center in the brain. The brain then sends signals to the body to produce nausea and vomiting.
Another substance, called substance P, is also released from the lining of the stomach and intestines with damage by chemotherapy, and is released together with serotonin. The substance P binds to another protein called "neurokinin-1 receptor" or NK-1 receptor. These proteins are found in the intestines and another portion of the brain called "tractus solitarius". The brain then signals the body to produce nausea and vomiting.
The stimulation of the serotonin proteins results in acute nausea and vomiting. The stimulation of the NK-1 protein results in delayed nausea and vomiting.
There are medications that could block the serotonin and NK-1 proteins. Serotonin blockers such as ondansetron or Zofran® are now considered the medications of choice to prevent and treat nausea and vomiting in the transplant setting. However, their use could still result in nausea and vomiting in up to 40-50% of patients.
Nausea and vomiting negatively impacts the quality of life of patients undergoing stem cell transplant for their multiple myeloma and lymphoma. It can affect their appetite and sleep; and can interfere with activity, social life and enjoyment of life. Therefore, it is important to find better ways to prevent and control nausea and vomiting associated with chemotherapy.
There are two new medications that are available for patients who receive regular doses of chemotherapy. One is the long acting preparation of the serotonin blocker called palonosetron or Aloxi®. It is used to control both acute and delayed nausea and vomiting. Another medication could block the NK-1 receptor, and is called aprepitant or Emend®. This prevents delayed nausea and vomiting.
Although these two medications are tested and proven to be effective among patients who receive regular doses of chemotherapy, they have not been tested in combination among patients who undergo high doses of chemotherapy in the setting of autologous stem cell transplant.
The purpose of this study is to evaluate if the combination of these two medications, together with small doses of steroids (dexamethasone), would be effective in preventing both acute and delayed vomiting associated with high doses of chemotherapy and stem cell transplant for patients with multiple myeloma and lymphoma. The usual way to administer palonosetron is by single injection in the vein before chemotherapy. This is shown to be effective for chemotherapy given for 1 day. Since chemotherapy regimen for transplant requires multiple days of treatment, palonosetron will also be administered on multiple days thereby delivering higher doses of this drug. Aprepitant would be administered at standard doses. This study would assess if combining palonosetron and aprepitant as well as giving multiple and higher doses of palonosetron would be safe and effective in the control of nausea and vomiting in the setting of transplant. The study would evaluate the effect of combined palonosetron and aprepitant on the quality of life with regards to nausea and vomiting, of patients undergoing transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melphalan, dexamethasone, aprepitant, palonosetron | Experimental | Drug: Palonosetron, Drug: Aprepitant, Drug: DexamethasoneGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalonosetronAlso: AloxiPalonosetron 0.25 mg IV over 30 seconds | Drug | Melphalan, dexamethasone, aprepitant, palonosetron |
| AprepitantAlso: EmendAprepitant 125 mg PO and Aprepitant 80 mg PO | Drug | Melphalan, dexamethasone, aprepitant, palonosetron |
| DexamethasoneAlso: DecadronDexamethasone 4 mg IV and Dexamethasone 4 mg IV push | Drug | Melphalan, dexamethasone, aprepitant, palonosetron |
Primary outcome
Overall Emetic Response: Acute
Time frame: 24 hours after chemotherapy
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.
Overall Emetic Response: Delayed
Time frame: 24 to 72 hours after chemotherapy
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.
Overall Emetic Response: Extended
Time frame: 72 hours after chemotherapy
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.
Overall Emetic Response
Time frame: At leaset 24 hours to more than 72 hours after chemotherapy
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.
1 secondary outcome
Impact of Nausea and Vomiting on the Quality of Life of Patients Undergoing Autologous HSCT
Time frame: 24 hours, Day 3, Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Aljitawi, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron, Aprepitant and Dexamethasone in people with Myeloma, Plasma-Cell and Lymphoma, Malignant, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Emetic Response: Acute (time frame: 24 hours after chemotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.