Trial Outcomes & Findings for Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea (NCT NCT00781768)

Last Updated: 2018-07-27

Results Overview

Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

181 participants

Primary outcome timeframe

14 days

Results posted on

2018-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Standard PO Ondanestron + Dexamethason Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Overall Study STARTED	89	92
Overall Study COMPLETED	89	90
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard PO Ondanestron + Dexamethason Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Overall Study Not transplanted.	0	2

Baseline Characteristics

Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard PO Ondanestron + Dexamethason n=89 Participants Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason n=90 Participants Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Total n=179 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	50 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Diagnosis Non-Hodgkin lymphoma	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Diagnosis Acute Myelogenous Leukemia	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Diagnosis Multiple Myeloma	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Diagnosis Acut Lymphoblastic Lymphoma	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Diagnosis Hodgkin's lymphoma	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Diagnosis Chronic Myelogenous Leukemia	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Diagnosis Other	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Setting Inpatient	69 Participants n=5 Participants	74 Participants n=7 Participants	143 Participants n=5 Participants
Setting Outpatient	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Graft Type Autologous-peripheral blood stem cell transplant	48 Participants n=5 Participants	41 Participants n=7 Participants	89 Participants n=5 Participants
Graft Type Related Allo-PBPCT	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Graft Type Related autologous bone marrow transplant	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Graft Type Matched unrelated donor PBPCT	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Graft Type Matched unrelated donor BMT	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Graft Type Cord as in umbilical cord	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Preparative Regimen Total body irradiation/Cyclophosphamide	33 Participants n=5 Participants	46 Participants n=7 Participants	79 Participants n=5 Participants
Preparative Regimen I.V. Busulfan/Cy	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Preparative Regimen Prescribed orally Bu/Cy	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Preparative Regimen TBI/Etoposide/Cy	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Preparative Regimen BCV	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
History of prior nausea or vomiting with chemotherapy Yes	55 Participants n=5 Participants	59 Participants n=7 Participants	114 Participants n=5 Participants
History of prior nausea or vomiting with chemotherapy No	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
History of prior nausea or vomiting with chemotherapy Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
History of prior nausea or vomiting with radiation therapy Yes	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
History of prior nausea or vomiting with radiation therapy No	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
History of prior nausea or vomiting with radiation therapy Unknown	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 179 patients receiving autologous and allogeneic hematopoietic stem cell transplants.

Outcome measures

Outcome measures
Measure	Standard PO Ondanestron + Dexamethason n=89 Participants Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason n=90 Participants Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Complete Response Rates Among Standard of Care and Combination Therapy Groups. Complete Responder	58 Participants	73 Participants
Complete Response Rates Among Standard of Care and Combination Therapy Groups. Not Complete Responder	31 Participants	17 Participants

Adverse Events

Standard PO Ondanestron + Dexamethason

Serious events: 2 serious events

Other events: 52 other events

Deaths: 2 deaths

Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason

Serious events: 5 serious events

Other events: 59 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Standard PO Ondanestron + Dexamethason n=89 participants at risk Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason n=90 participants at risk Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Infections and infestations Sepsis	0.00% 0/89 • Adverse events data were collected through study completion, or 7 years.	4.4% 4/90 • Number of events 4 • Adverse events data were collected through study completion, or 7 years.
Infections and infestations Veno-occlusive disease of the liver	0.00% 0/89 • Adverse events data were collected through study completion, or 7 years.	1.1% 1/90 • Number of events 1 • Adverse events data were collected through study completion, or 7 years.
Infections and infestations Viral Pneumonia/Encephalitis and fungal Pneumonia	2.2% 2/89 • Number of events 2 • Adverse events data were collected through study completion, or 7 years.	0.00% 0/90 • Adverse events data were collected through study completion, or 7 years.

Other adverse events

Other adverse events
Measure	Standard PO Ondanestron + Dexamethason n=89 participants at risk Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.	Aprepitant (MK-869) + Standard PO Ondanestron + Dexamethason n=90 participants at risk Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
Gastrointestinal disorders Diarrhea	58.4% 52/89 • Number of events 52 • Adverse events data were collected through study completion, or 7 years.	65.6% 59/90 • Number of events 59 • Adverse events data were collected through study completion, or 7 years.
General disorders Headache	51.7% 46/89 • Number of events 46 • Adverse events data were collected through study completion, or 7 years.	48.9% 44/90 • Number of events 44 • Adverse events data were collected through study completion, or 7 years.
General disorders Fatigue	38.2% 34/89 • Number of events 34 • Adverse events data were collected through study completion, or 7 years.	41.1% 37/90 • Number of events 37 • Adverse events data were collected through study completion, or 7 years.
Gastrointestinal disorders Constipation	23.6% 21/89 • Number of events 21 • Adverse events data were collected through study completion, or 7 years.	31.1% 28/90 • Number of events 28 • Adverse events data were collected through study completion, or 7 years.
General disorders Fever	21.3% 19/89 • Number of events 19 • Adverse events data were collected through study completion, or 7 years.	24.4% 22/90 • Number of events 22 • Adverse events data were collected through study completion, or 7 years.
General disorders Hiccups	22.5% 20/89 • Number of events 20 • Adverse events data were collected through study completion, or 7 years.	23.3% 21/90 • Number of events 21 • Adverse events data were collected through study completion, or 7 years.
Gastrointestinal disorders Heartburn	6.7% 6/89 • Number of events 6 • Adverse events data were collected through study completion, or 7 years.	13.3% 12/90 • Number of events 12 • Adverse events data were collected through study completion, or 7 years.
General disorders Lightheartedness/dizziness	5.6% 5/89 • Number of events 5 • Adverse events data were collected through study completion, or 7 years.	7.8% 7/90 • Number of events 7 • Adverse events data were collected through study completion, or 7 years.

Additional Information

Patrick Stiff, M.D.

Loyola University Medical Center

Phone: 708-327-3148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place