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. - EmNa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004956-38-DE

Enrollment

362

Registered

2005-09-22

Start date

2005-06-06

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

Product Name: EMEND Pharmaceutical Form: Capsule, hard INN or Proposed INN: Aprepitant Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women >/=18 years 2) Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and autologous peripheral stemcell transplantation 3) Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Patients suffering from nausea and vomiting during the last 12 hours prior to planned high-dose chemotherapy 2) Patients receiving antiemetics 24 hours prior to planned high-dose chemotherapy 3) Intake of steroids 4) 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 5) Simultaneous intake of pimozide, terfenadine, astemizole 6) Pregnant or nursing woman 7) Mental condition rendering the subject incapable to understand the nature, scope and possible consequences of the study 8) Non-compliance in completing the subject´s diary and FLIE-score

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of Aprepitant combined with the standard therapy (Kevatril plus Dexamethasone) on acute and delayed chemotherapy-induced nausea and vomiting during and 5 days after a high-dose chemotherapy.;Secondary Objective: The secondary objectives are to evaluate the effect on emesis in the acute and delayed phase during and post chemotherapy, the effect on vomiting regardless of use of rescue therapy, episodes of nausea (no or no significant nausea), the use of rescue therapy, the impact on daily life and the safety and tolerability of the study medication.;Primary end point(s): Overall complete response (no emesis and no rescue therapy) during and post chemotherapy (0-120h)	—

Measure

Time frame

Main Objective: To investigate the efficacy of Aprepitant combined with the standard therapy (Kevatril plus Dexamethasone) on acute and delayed chemotherapy-induced nausea and vomiting during and 5 days after a high-dose chemotherapy.;Secondary Objective: The secondary objectives are to evaluate the effect on emesis in the acute and delayed phase during and post chemotherapy, the effect on vomiting regardless of use of rescue therapy, episodes of nausea (no or no significant nausea), the use of rescue therapy, the impact on daily life and the safety and tolerability of the study medication.;Primary end point(s): Overall complete response (no emesis and no rescue therapy) during and post chemotherapy (0-120h)

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026