Trial Outcomes & Findings for A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma (NCT NCT02919670)
NCT ID: NCT02919670
Last Updated: 2023-03-16
Results Overview
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
14 days
Results posted on
2023-03-16
Participant Flow
Participants were recruited from 10/5/2016 - 10/05/2017
Of 114, 6 patients did not receive transplant and 1 patient had a delayed transplant..5 patients withdrew consent , 1 patient did not take any amount due to the finding mold, 1 patient did not take due to subjects inability to swallow liquids and 1 patient had an insurance issue. Thus a total of 15 patients are excluded. (114-15=99).
Participant milestones
| Measure |
Enterade and Standard Supportive Care
* Two 8 oz. bottles of Enterade will be administered daily
* Enterade will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Enterade
Standard Supportive Care
|
Placebo and Standard Supportive Care
* Two 8 oz. bottles of Placebo will be administered daily
* Placebo will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Placebo
Standard Supportive Care
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
COMPLETED
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
43
|
39
|
Reasons for withdrawal
| Measure |
Enterade and Standard Supportive Care
* Two 8 oz. bottles of Enterade will be administered daily
* Enterade will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Enterade
Standard Supportive Care
|
Placebo and Standard Supportive Care
* Two 8 oz. bottles of Placebo will be administered daily
* Placebo will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Placebo
Standard Supportive Care
|
|---|---|---|
|
Overall Study
Only 17 participants met compliance
|
43
|
39
|
Baseline Characteristics
A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Enterade and Standard Supportive Care
n=49 Participants
* Two 8 oz. bottles of Enterade will be administered daily
* Enterade will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Enterade
Standard Supportive Care
|
Placebo and Standard Supportive Care
n=50 Participants
* Two 8 oz. bottles of Placebo will be administered daily
* Placebo will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Placebo
Standard Supportive Care
|
Total
n=99 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
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Count of participants
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Only 17 participants met the protocol definition of compliance
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Maximum Daily Stool Frequency
Day +1 to Day +7
|
5 number of stools per day
Interval 1.0 to 18.0
|
6 number of stools per day
Interval 1.0 to 30.0
|
|
Maximum Daily Stool Frequency
Day +8 to Day +14
|
6 number of stools per day
Interval 0.0 to 34.0
|
5 number of stools per day
Interval 1.0 to 75.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Day +1 to Day +7
|
22 Participants
|
26 Participants
|
|
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Day +8 to Day +14
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 45 daysPopulation: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Duration Of Hospitalization (Days) From Admission To Discharge
|
17 days
Interval 14.0 to 29.0
|
17 days
Interval 13.0 to 45.0
|
SECONDARY outcome
Timeframe: baseline and day 14Population: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Percent Change in Weight From Baseline to Day 14
|
-2.5 percent change
Interval -18.4 to 11.6
|
-2.2 percent change
Interval -9.0 to 45.9
|
SECONDARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Median Amount Of Anti-Diarrheal Medications
|
27 mg
Interval 2.0 to 264.0
|
30 mg
Interval 2.0 to 160.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Patients who take the study drug two 8 oz. bottles (480 ml) daily for at least 11 days are regarded as compliant. Compliance is assessed among patients who received any amount of the study drug (N=99).Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Calorie Consumption
Admission
|
1848.5 calories
Interval 352.0 to 2919.0
|
1790 calories
Interval 680.0 to 2793.0
|
|
Calorie Consumption
D+7
|
625.5 calories
Interval 0.0 to 2523.0
|
720 calories
Interval 0.0 to 2770.0
|
|
Calorie Consumption
D+14
|
800 calories
Interval 0.0 to 2300.0
|
922 calories
Interval 0.0 to 3174.0
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Only 17 participants met the protocol definition of compliance
Outcome measures
| Measure |
Enterade
n=49 Participants
Participants who received Enterade
|
Placebo
n=50 Participants
Participants who received placebo
|
|---|---|---|
|
Number of Participants With Fever or Neutropenia
Fever
|
3 Participants
|
3 Participants
|
|
Number of Participants With Fever or Neutropenia
Neutrophil count decreased
|
28 Participants
|
30 Participants
|
Adverse Events
Enterade and Standard Supportive Care
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo and Standard Supportive Care
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Enterade and Standard Supportive Care
n=49 participants at risk
* Two 8 oz. bottles of Enterade will be administered daily
* Enterade will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Enterade
Standard Supportive Care
|
Placebo and Standard Supportive Care
n=50 participants at risk
* Two 8 oz. bottles of Placebo will be administered daily
* Placebo will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Placebo
Standard Supportive Care
|
|---|---|---|
|
Infections and infestations
Clostridium septicum septic shock
|
0.00%
0/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
2.0%
1/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
Other adverse events
| Measure |
Enterade and Standard Supportive Care
n=49 participants at risk
* Two 8 oz. bottles of Enterade will be administered daily
* Enterade will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Enterade
Standard Supportive Care
|
Placebo and Standard Supportive Care
n=50 participants at risk
* Two 8 oz. bottles of Placebo will be administered daily
* Placebo will be given orally from admission until day +14 or until discharge
* Standard Supportive Care will be administered according to institution's practice
Placebo
Standard Supportive Care
|
|---|---|---|
|
Infections and infestations
Colitis
|
6.1%
3/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
6.0%
3/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
7/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
24.0%
12/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
2.0%
1/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
|
Gastrointestinal disorders
Esophagitis
|
4.1%
2/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
10.0%
5/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
|
Infections and infestations
Mucositis oral
|
8.2%
4/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
0.00%
0/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
0.00%
0/50 • 14 days
The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place