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Trial Title:
Efficacy and Safety of Aprepitant in Subjects With Multiple Myeloma During and After High-dose Chemotherapy
NCT ID:
NCT00571168
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
chemotherapy induced nausea and vomiting
autologous peripheral blood stemcell transplantation
high dose chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Emend
Description:
125 mg/d on day 1; 80 mg/d on day 2-4
Arm group label:
A
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo capsules on day 1-4
Arm group label:
B
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 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).
2. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Men and women >/= 18 years
- Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and
autologous peripheral stemcell transplantation
- Signed informed consent
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Heidelberg, Department V
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Gerlinde Egerer, MD
Email:
Principal Investigator
Start date:
July 2005
Completion date:
December 2010
Lead sponsor:
Agency:
Heidelberg University
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Heidelberg University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00571168
