Trial Outcomes & Findings for Multi-day Doses in Prevention of Nausea and Emesis (NCT NCT00600353)
NCT ID: NCT00600353
Last Updated: 2017-03-09
Results Overview
Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.
COMPLETED
PHASE2
20 participants
24 hours after chemotherapy
2017-03-09
Participant Flow
20 patients undergoing Autologous Stem Cell Transplant (ASCT) for multiple myeloma (MM) (n=10) and relapsed lymphoma (n=10) at the University of Kansas Medical Center were enrolled. 2 patients were excluded from analysis - both patients met exclusion criteria
Emetic responses were assessed by daily patient diaries and the Multinational Association for Supportive Care in Cancer Antiemetic Tool (MAT). Nausea was measured using a Nausea Visual Score (NVS) of 0 to 10 with score of 0 having no nausea. A "modified" Osoba module was used to assess quality of life (QOL).
Participant milestones
| Measure |
Group A - Subjects With Multiple Myeloma
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group A - Subjects With Multiple Myeloma
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Study
history of malignancy within 5 years
|
1
|
0
|
|
Overall Study
History of prepartive regimen
|
0
|
1
|
Baseline Characteristics
Multi-day Doses in Prevention of Nausea and Emesis
Baseline characteristics by cohort
| Measure |
Subjects With Multiple Myeloma
n=9 Participants
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
Group B Lymphoma
n=9 Participants
Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
emetic response, adverse events, quality of care
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after chemotherapyComplete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.
Outcome measures
| Measure |
Group A - Subjects With Multiple Myeloma
n=9 Participants
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
n=9 Participants
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Emetic Response: Acute
mr
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Acute
Failure
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Acute
NSN
|
9 Participants
|
9 Participants
|
|
Overall Emetic Response: Acute
CC
|
5 Participants
|
9 Participants
|
|
Overall Emetic Response: Acute
CR
|
1 Participants
|
0 Participants
|
|
Overall Emetic Response: Acute
MR
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 to 72 hours after chemotherapyComplete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.
Outcome measures
| Measure |
Group A - Subjects With Multiple Myeloma
n=9 Participants
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
n=9 Participants
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Emetic Response: Delayed
MR
|
6 Participants
|
5 Participants
|
|
Overall Emetic Response: Delayed
mR
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Delayed
Failure
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Delayed
NSN
|
0 Participants
|
8 Participants
|
|
Overall Emetic Response: Delayed
CC
|
2 Participants
|
4 Participants
|
|
Overall Emetic Response: Delayed
CR
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 72 hours after chemotherapyComplete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.
Outcome measures
| Measure |
Group A - Subjects With Multiple Myeloma
n=9 Participants
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
n=9 Participants
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Emetic Response: Extended
CC
|
1 Participants
|
2 Participants
|
|
Overall Emetic Response: Extended
CR
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Extended
MR
|
7 Participants
|
7 Participants
|
|
Overall Emetic Response: Extended
mR
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Extended
Failure
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response: Extended
NSN
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At leaset 24 hours to more than 72 hours after chemotherapyClinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.
Outcome measures
| Measure |
Group A - Subjects With Multiple Myeloma
n=9 Participants
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Group B - Subjects With Relpased Lymphoma
n=9 Participants
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Overall Emetic Response
CC
|
0 Participants
|
1 Participants
|
|
Overall Emetic Response
CR
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response
MR
|
8 Participants
|
6 Participants
|
|
Overall Emetic Response
Failure
|
0 Participants
|
0 Participants
|
|
Overall Emetic Response
NSN
|
6 Participants
|
5 Participants
|
|
Overall Emetic Response
mR
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 hours, Day 3, Day 7To determine quality of life, subjects' responses to the modified Osoba modules were converted to a 0 - 100 scale, with higher scores indicative of better QOL
Outcome measures
Outcome data not reported
Adverse Events
Subjects With Multiple Myeloma
Patients With Lymphoma
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects With Multiple Myeloma
n=9 participants at risk
Group A: Subjects with Multiple Myeloma
* Conditioning regimen, over a 7 day period, includes:
* Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
|
Patients With Lymphoma
n=9 participants at risk
Group B: Subjects with Lymphoma
* Conditioning regimen, over a 7 day period, includes: (BEAC)
* BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
|
|---|---|---|
|
Infections and infestations
Infection, Abdomen NOS
|
0.00%
0/9 • Day +30
|
11.1%
1/9 • Number of events 1 • Day +30
|
|
Gastrointestinal disorders
Gastric Mucositis
|
0.00%
0/9 • Day +30
|
11.1%
1/9 • Number of events 1 • Day +30
|
|
Gastrointestinal disorders
Gallbladder pain
|
0.00%
0/9 • Day +30
|
11.1%
1/9 • Number of events 1 • Day +30
|
|
Infections and infestations
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • Day +30
|
11.1%
1/9 • Number of events 1 • Day +30
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/9 • Day +30
|
11.1%
1/9 • Number of events 1 • Day +30
|
|
Cardiac disorders
Conduction disorder
|
11.1%
1/9 • Number of events 1 • Day +30
|
0.00%
0/9 • Day +30
|
|
Infections and infestations
Infection, Catheter-related
|
11.1%
1/9 • Number of events 1 • Day +30
|
0.00%
0/9 • Day +30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place