Multiple Myeloma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Stem Cell Transplant
Brief summary
This research study is evaluating Enterade, a supplement, as a possible treatment for the side effects caused by Stem Cell Transplant. The following interventions will be involved in this study: * Enterade plus standard supportive care * Placebo plus standard supportive care. The placebo will be a mixture of water, electrolytes, and sweetener.
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease, or in this case, the side effects from a standard treatment for Stem Cell Transplant side effect. Investigational means that the intervention is being studied. In this research study, the investigators are evaluating Enterade/Placebo plus standard supportive care for the treatment of the side effects caused by transplant. Enterade works by rehydrating the intestinal cells, thereby helping to restore normal bowel function. The ingredients in Enterade are generally recognized as safe by the Food and Drug Administration. This research study is hoping to learn if adding Enterade to the standard supportive care regimen for the participant transplant will help reduce the side effects from the transplant.
Interventions
Sponsors
Entrinsic Health
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have histologically or cytologically confirmed Multiple Myeloma, or Non-Hodgkin Lymphoma and must be undergoing Melphalan conditioning for autologous HSCT. * Age equal or greater than 18 years old. * ECOG performance status ≤2 (Karnofsky ≥60%) * Participants must have adequate organ and marrow function to proceed to transplant. * Ability to tolerate thin liquids by mouth at the time of admission. * The effects of Enterade® on the developing human fetus are unknown. For this reason and other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the time of study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the trial. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to chemotherapy agents administered during this time period. * Participants who are receiving any other investigational agents. Participants who are receiving standard of care induction therapy on a clinical trial may be eligible after discussion with the overall principal investigator. * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Known allergy to Stevia. * Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection. * Participants with evidence of diarrhea as defined by three or more loose or liquid stools per day or loose watery stool (greater volume of stool), that occurs more frequently than usual and lasting for more than three days prior to admission, history of inflammatory bowel disease, irritable bowel syndrome, colectomy or bariatric surgery, Celiac disease. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and nursing women are excluded from this study because of teratogenicity and toxicity risks associated with the conditioning regimen for patients undergoing autologous HSCT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity | 14 days | Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | 14 days |
| Duration Of Hospitalization (Days) From Admission To Discharge | Up to 45 days |
| Percent Change in Weight From Baseline to Day 14 | baseline and day 14 |
| Maximum Daily Stool Frequency | 14 days |
| the Tolerability of Enterade® as Measured by the Number of Compliant Patients | 14 days |
| Calorie Consumption | 14 days |
| Number of Participants With Fever or Neutropenia | 14 days |
| Median Amount Of Anti-Diarrheal Medications | 14 days |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 10/5/2016 - 10/05/2017
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Only 17 participants met compliance | 43 | 39 |
Baseline characteristics
| Characteristic | Enterade and Standard Supportive Care | Placebo and Standard Supportive Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 44 Participants | 88 Participants |
| Age, Continuous | 61 years | 59 years | 60 years |
| Count of participants | 49 Participants | 50 Participants | 99 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 45 Participants | 44 Participants | 89 Participants |
| Region of Enrollment United States | 49 Participants | 50 Participants | 99 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 34 Participants | 40 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 1 / 50 |
| other Total, other adverse events | 18 / 49 | 21 / 50 |
| serious Total, serious adverse events | 0 / 49 | 1 / 50 |
Outcome results
Primary
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
Time frame: 14 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enterade | Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity | 18 Participants |
| Placebo | Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity | 21 Participants |
Secondary
Calorie Consumption
Time frame: 14 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enterade | Calorie Consumption | D+7 | 625.5 calories |
| Enterade | Calorie Consumption | Admission | 1848.5 calories |
| Enterade | Calorie Consumption | D+14 | 800 calories |
| Placebo | Calorie Consumption | Admission | 1790 calories |
| Placebo | Calorie Consumption | D+7 | 720 calories |
| Placebo | Calorie Consumption | D+14 | 922 calories |
Secondary
Duration Of Hospitalization (Days) From Admission To Discharge
Time frame: Up to 45 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enterade | Duration Of Hospitalization (Days) From Admission To Discharge | 17 days |
| Placebo | Duration Of Hospitalization (Days) From Admission To Discharge | 17 days |
Secondary
Maximum Daily Stool Frequency
Time frame: 14 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Enterade | Maximum Daily Stool Frequency | Day +1 to Day +7 | 5 number of stools per day |
| Enterade | Maximum Daily Stool Frequency | Day +8 to Day +14 | 6 number of stools per day |
| Placebo | Maximum Daily Stool Frequency | Day +1 to Day +7 | 6 number of stools per day |
| Placebo | Maximum Daily Stool Frequency | Day +8 to Day +14 | 5 number of stools per day |
Secondary
Median Amount Of Anti-Diarrheal Medications
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enterade | Median Amount Of Anti-Diarrheal Medications | 27 mg |
| Placebo | Median Amount Of Anti-Diarrheal Medications | 30 mg |
Secondary
Number of Participants With Fever or Neutropenia
Time frame: 14 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enterade | Number of Participants With Fever or Neutropenia | Fever | 3 Participants |
| Enterade | Number of Participants With Fever or Neutropenia | Neutrophil count decreased | 28 Participants |
| Placebo | Number of Participants With Fever or Neutropenia | Fever | 3 Participants |
| Placebo | Number of Participants With Fever or Neutropenia | Neutrophil count decreased | 30 Participants |
Secondary
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Time frame: 14 days
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enterade | Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | Day +1 to Day +7 | 22 Participants |
| Enterade | Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | Day +8 to Day +14 | 25 Participants |
| Placebo | Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | Day +1 to Day +7 | 26 Participants |
| Placebo | Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | Day +8 to Day +14 | 22 Participants |
Secondary
Percent Change in Weight From Baseline to Day 14
Time frame: baseline and day 14
Population: Only 17 participants met the protocol definition of compliance
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enterade | Percent Change in Weight From Baseline to Day 14 | -2.5 percent change |
| Placebo | Percent Change in Weight From Baseline to Day 14 | -2.2 percent change |
Secondary
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
Time frame: 14 days
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enterade | the Tolerability of Enterade® as Measured by the Number of Compliant Patients | 6 Participants |
| Placebo | the Tolerability of Enterade® as Measured by the Number of Compliant Patients | 11 Participants |