Efficacy and Safety of Aprepitant in Subjects With Multiple Myeloma During and After High-dose Chemotherapy

NCT00571168 | Unknown Phase 3

• 2 other identifiers: EmNa (2001-004956-38)EudraCT-No: 2004-004956-38
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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).
2. 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.

Conditions

Multiple Myeloma

Keywords

chemotherapy induced nausea and vomiting; autologous peripheral blood stemcell transplantation; high dose chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall complete response (no emesis and no rescue therapy)

  During and post chemotherapy (0-120 h)

Secondary Outcomes (8)

• Complete response acute/delayed phase

  During and post chemotherapy (0-120h)

• Vomiting event rate

  During and post chemotherapy (0-120h)

• No emesis (FLIE-Score)

  During and post chemotherapy (0-120h)

• No (significant) nausea (VAS < 5 mm;(< 25 mm))

  During and post chemotherapy (0-120h)

• No rescue therapy

  During and post chemotherapy (0-120h)

Study Arms (2)

A

EXPERIMENTAL

Aprepitant plus standard therapy (Kevatril + Dexamethason) on day 1-4

Drug: Emend

B

PLACEBO COMPARATOR

Placebo plus standard therapy (Kevatril + Dexamethason) on day 1-4

Drug: Placebo

Interventions

Emend DRUG

125 mg/d on day 1; 80 mg/d on day 2-4

A

Placebo DRUG

Placebo capsules on day 1-4

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \>/= 18 years
• Patients with multiple myeloma receiving high-dose chemotherapy (Melphalan) and autologous peripheral stemcell transplantation
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospital of Heidelberg, Department V

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 25225424 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gerlinde Egerer, MD

  University Hospital of Heidelberg; Im Neuenheimer Feld 410; 69120 Heidelberg/ Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerlinde Egerer, MD

CONTACT

++49(0)6221 56-8002; Gerlinde.Egerer@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: July 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

DE (1)