Multiple MyelomaPhase 3EmNaNCT00571168
Efficacy and Safety of Aprepitant in Subjects With Multiple Myeloma During and After High-dose Chemotherapy
A Phase 3 study testing Emend in people with Multiple Myeloma, run by Heidelberg University at 1 site in Germany.
Trial summary
1. Scientific background In patients with multiple myeloma high-dose chemotherapy followed by autologous stemcell transplantation is preferred to conventional therapy, since the superiority in respect to complete remission, complete remission duration, event-free survival and overall survival has been proven within… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Emend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Men and women >/= 18 years
- Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and autologous peripheral stemcell transplantation
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Department V
Heidelberg, 69120
Gerlinde Egerer, MD
About this study
Official title: 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.
- Scientific background In patients with multiple myeloma high-dose chemotherapy followed by autologous stemcell transplantation is preferred to conventional therapy, since the superiority in respect to complete remission, complete remission duration, event-free survival and overall survival has been proven within well controlled clinical trials (Fassas et al., 2002; Goldschmidt et al., 2003). Nausea and vomiting are well known and the most distressing side-effects of a high dose chemotherapy regimen. The administration of selective 5-HT3-receptor antagonists (5-HT3 RAs) in combination with a corticosteroid (= antiemetic standard therapy) is effective for the prevention of those adverse effects in 70 to 80 % of patients. However, 25 to 40 % of the patients still suffer from vomiting and nausea in the delayed phase of the chemotherapy. Superior protection could be achieved with the addition of Aprepitant (EMEND®) to the antiemetic standard therapy in acute and delayed phases of highly emetogenic chemotherapies. The enhanced antiemetic protection can be maintained over multiple chemotherapy-cycles to an extent superior to that of standard therapy alone (de Wit et al., 2003). Furthermore addition of Aprepitant (EMEND®) to standard therapy was generally well tolerated and the impact of chemotherapy-induced nausea and vomiting (CINV) on daily life was significantly reduced (Hesketh et al., 2003; Dando \& Perry, 2004).
- Trial Rationale Aprepitant (EMEND®) is a selective high-affinity receptor antagonist of human substance P/neurokinin-1 (NK1) and has been shown to inhibit emesis induced by cytotoxic chemotherapeutic agents and augments the antiemetic activity of 5-HT3 RAs (e.g. Granisetron, Ondansetron) and corticosteroids (e.g. Dexamethasone). Thus Aprepitant (EMEND®) in addition to antiemetic standard therapy has been shown to possess powerful superior protection and has been reported in several clinical trials to significantly improve both acute and delayed CINV.
The aim of this study is to evaluate, during and up to 7 days after high-dose chemotherapy with Melphalan (moderate emetogenic drug) followed by autologous peripheral blood stemcell transplantation, an antiemetic treatment regimen in respect to efficacy and safety in patients with multiple myeloma. To the best of our knowledge effects of Aprepitant on Melphalan induced CINV have never been investigated.
- Conditions
- Multiple Myeloma
- Being tested
- Emend, Placebo
- Keywords
- chemotherapy induced nausea and vomiting, autologous peripheral blood stemcell transplantation, high dose chemotherapy
- Medical subject headings
- Multiple Myeloma, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmendDrug
125 mg/d on day 1; 80 mg/d on day 2-4
PlaceboDrug
Placebo capsules on day 1-4
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aprepitant plus standard therapy (Kevatril + Dexamethason) on day 1-4 Receives: Drug: Emend |
| B | Placebo comparator | Placebo plus standard therapy (Kevatril + Dexamethason) on day 1-4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complete response (no emesis and no rescue therapy)
Measured: During and post chemotherapy (0-120 h)
Secondary outcomes (8)
Complete response acute/delayed phase
Measured: During and post chemotherapy (0-120h)
Vomiting event rate
Measured: During and post chemotherapy (0-120h)
No emesis (FLIE-Score)
Measured: During and post chemotherapy (0-120h)
No (significant) nausea (VAS < 5 mm;(< 25 mm))
Measured: During and post chemotherapy (0-120h)
No rescue therapy
Measured: During and post chemotherapy (0-120h)
Total control (no emesis, no nausea, no rescue therapy)
Measured: During and post chemotherapy (0-120h)
No impact on daily life
Measured: During and post chemotherapy (0-120h)
AEs
Measured: During and post chemotherapy (0-120h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJul 2005
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Gerlinde Egerer, MD, Principal investigator, University Hospital of Heidelberg; Im Neuenheimer Feld 410; 69120 Heidelberg/ Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571168
- Sponsor's protocol ID
- EmNa (2001-004956-38)
- Other IDs
- EudraCT-No: 2004-004956-38
- Acronym
- EmNa
- Status last verified
- Jan 2010
- First submitted
- 10 Dec 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmitt T, Goldschmidt H, Neben K, Freiberger A, Husing J, Gronkowski M, Thalheimer M, Pelzl le H, Mikus G, Burhenne J, Ho AD, Egerer G. Aprepitant, granisetron, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting after high-dose melphalan in autologous transplantation for multiple myeloma: results of a randomized, placebo-controlled phase III trial. J Clin Oncol. 2014 Oct 20;32(30):3413-20. doi: 10.1200/JCO.2013.55.0095. Epub 2014 Sep 15.
PubMed 25225424
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00571168
- Acronym / sponsor ID
- EmNa / EmNa (2001-004956-38)
- Conditions
- Multiple Myeloma
- Keywords
- chemotherapy induced nausea and vomiting, autologous peripheral blood stemcell transplantation, high dose chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2005
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Scientific background In patients with multiple myeloma high-dose chemotherapy followed by autologous stemcell transplantation is preferred to conventional therapy, since the superiority in respect to complete remission, complete remission duration, event-free survival and overall survival has been proven within well controlled clinical trials (Fassas et al., 2002; Goldschmidt et al., 2003). Nausea and vomiting are well known and the most distressing side-effects of a high dose chemotherapy regimen. The administration of selective 5-HT3-receptor antagonists (5-HT3 RAs) in combination with a corticosteroid (= antiemetic standard therapy) is effective for the prevention of those adverse effects in 70 to 80 % of patients. However, 25 to 40 % of the patients still suffer from vomiting and nausea in the delayed phase of the chemotherapy. Superior protection could be achieved with the addition of Aprepitant (EMEND®) to the antiemetic standard therapy in acute and delayed phases of highly emetogenic chemotherapies. The enhanced antiemetic protection can be maintained over multiple chemotherapy-cycles to an extent superior to that of standard therapy alone (de Wit et al., 2003). Furthermore addition of Aprepitant (EMEND®) to standard therapy was generally well tolerated and the impact of chemotherapy-induced nausea and vomiting (CINV) on daily life was significantly reduced (Hesketh et al., 2003; Dando \& Perry, 2004).
- Trial Rationale Aprepitant (EMEND®) is a selective high-affinity receptor antagonist of human substance P/neurokinin-1 (NK1) and has been shown to inhibit emesis induced by cytotoxic chemotherapeutic agents and augments the antiemetic activity of 5-HT3 RAs (e.g. Granisetron, Ondansetron) and corticosteroids (e.g. Dexamethasone). Thus Aprepitant (EMEND®) in addition to antiemetic standard therapy has been shown to possess powerful superior protection and has been reported in several clinical trials to significantly improve both acute and delayed CINV.
The aim of this study is to evaluate, during and up to 7 days after high-dose chemotherapy with Melphalan (moderate emetogenic drug) followed by autologous peripheral blood stemcell transplantation, an antiemetic treatment regimen in respect to efficacy and safety in patients with multiple myeloma. To the best of our knowledge effects of Aprepitant on Melphalan induced CINV have never been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EmendAprepitant plus standard therapy (Kevatril + Dexamethason) on day 1-4 |
| B | Placebo comparator | Drug: PlaceboPlacebo plus standard therapy (Kevatril + Dexamethason) on day 1-4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women >/= 18 years
- Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and autologous peripheral stemcell transplantation
- Signed informed consent
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Emend125 mg/d on day 1; 80 mg/d on day 2-4 | Drug | A |
| PlaceboPlacebo capsules on day 1-4 | Drug | B |
Primary outcome
Overall complete response (no emesis and no rescue therapy)
Time frame: During and post chemotherapy (0-120 h)
8 secondary outcomes
Complete response acute/delayed phase
Time frame: During and post chemotherapy (0-120h)
Vomiting event rate
Time frame: During and post chemotherapy (0-120h)
No emesis (FLIE-Score)
Time frame: During and post chemotherapy (0-120h)
No (significant) nausea (VAS < 5 mm;(< 25 mm))
Time frame: During and post chemotherapy (0-120h)
No rescue therapy
Time frame: During and post chemotherapy (0-120h)
Total control (no emesis, no nausea, no rescue therapy)
Time frame: During and post chemotherapy (0-120h)
No impact on daily life
Time frame: During and post chemotherapy (0-120h)
AEs
Time frame: During and post chemotherapy (0-120h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Derived from this study: PubMed 25225424Schmitt T, Goldschmidt H, Neben K, Freiberger A, Husing J, Gronkowski M, Thalheimer M, Pelzl le H, Mikus G, Burhenne J, Ho AD, Egerer G. Aprepitant, granisetron, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting after high-dose melphalan in autologous transplantation for multiple myeloma: results of a randomized, placebo-controlled phase III trial. J Clin Oncol. 2014 Oct 20;32(30):3413-20. doi: 10.1200/JCO.2013.55.0095. Epub 2014 Sep 15.
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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.
Gerlinde Egerer, MD principal investigator
University Hospital of Heidelberg; Im Neuenheimer Feld 410; 69120 Heidelberg/ Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Emend in people with Multiple Myeloma, run by Heidelberg University at 1 site in Germany.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jan 2010. 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 Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerlinde Egerer, MD (++49(0)6221 56-8002, Gerlinde.Egerer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complete response (no emesis and no rescue therapy) (time frame: During and post chemotherapy (0-120 h)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571168, which also lists 1 linked publication.
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 12 Jan 2010.