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

NCT02919670 | Completed Results DMC

• 1 other identifier: 16-329
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Non-Hodgkin's Lymphoma

Keywords

Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• 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

  14 days

Secondary Outcomes (8)

• Maximum Daily Stool Frequency

  14 days

• 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

• Median Amount Of Anti-Diarrheal Medications

  14 days

Study Arms (2)

Enterade and Standard Supportive Care

EXPERIMENTAL

* 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

Dietary Supplement: Enterade; Other: Standard Supportive Care

Placebo and Standard Supportive Care

PLACEBO COMPARATOR

* 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

Dietary Supplement: Placebo; Other: Standard Supportive Care

Interventions

Enterade DIETARY_SUPPLEMENT

Enterade and Standard Supportive Care

Placebo DIETARY_SUPPLEMENT

Placebo and Standard Supportive Care

Standard Supportive Care OTHER

Enterade and Standard Supportive Care; Placebo and Standard Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Entrinsic Health: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Results Point of Contact

• Title: Kelly Masone
• Organization: DFCI

kmasone@partners.org

6176324167

Study Officials

• Mahasweta Gooptu, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 16, 2023
• Results First Posted: March 16, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)