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N/A Completed N=99 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT02919670 ↗
Enrolled (actual)
99
Serious AEs
1.0%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity — 18; 21 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
18; 21
SECONDARY
Maximum Daily Stool Frequency
5; 6; 6; 5
SECONDARY
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
22; 26; 25; 22
SECONDARY
Duration Of Hospitalization (Days) From Admission To Discharge
17; 17
SECONDARY
Percent Change in Weight From Baseline to Day 14
-2.5; -2.2
SECONDARY
Median Amount Of Anti-Diarrheal Medications
27; 30
SECONDARY
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
6; 11
SECONDARY
Calorie Consumption
1848.5; 1790; 625.5; 720; 800; 922
SECONDARY
Number of Participants With Fever or Neutropenia
3; 3; 28; 30

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02919670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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