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
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/2/2018 |
Start Date: | October 2016 |
End Date: | April 2024 |
A Randomized Double-Blinded Phase 2 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
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.
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.
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.
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.
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.
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