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

• ClinicalTrials.gov Identifier: NCT02919670
• Recruitment Status: Active, not recruiting
• First Posted: September 29, 2016
• Last Update Posted: May 3, 2019
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Brett Glotzbecker, Dana-Farber Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma; Non-Hodgkin's Lymphoma	Dietary Supplement: Enterade; Dietary Supplement: Placebo; Other: Standard Supportive Care	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: October 2016
• Estimated Primary Completion Date: April 2020
• Estimated Study Completion Date: April 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Dietary Supplement: Enterade; Other: Standard Supportive Care
Placebo Comparator: 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	Dietary Supplement: Placebo; Other: Standard Supportive Care

Outcome Measures

Primary Outcome Measures :

1. The Incidence of NCI-CTCAE 4.0 Grade 3 or Higher Diarrhea GI Toxicity [ Time Frame: 14 days ]
   Evaluation will made using Fisher's exact test

Secondary Outcome Measures :

1. Average Total Daily Stool Volume [ Time Frame: 14 days ]
2. Average Daily Stool Frequency [ Time Frame: 14 days ]
3. Duration Of Hospitalization (Days) From Admission To Discharge [ Time Frame: 14 days ]
4. Change In Weight [ Time Frame: 14 days ]
5. Total Use Of Anti-Diarrheal Medications [ Time Frame: 14 days ]
6. Use Of Antibiotic Medications [ Time Frame: 14 days ]
7. To characterize the tolerability of Enterade® as measured by the average drinks per day. [ Time Frame: 14 days ]
8. Calorie Consumption [ Time Frame: 14 days ]
9. To assess stool inflammation with fecal lactoferrin on admission, and day +7 following Hematopoietic stem cell transplantation by collecting stool samples [ Time Frame: 7 days following hematopoietic stem cell transplantation ]
10. Frequency Of Fever And Neutropenia [ Time Frame: 14 days ]
11. Duration of Fever and Neutropenia [ Time Frame: 14 days ]
12. To characterize the tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial. [ Time Frame: 14 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Brett Glotzbecker, MD; Dana-Farber Cancer Institute

More Information

• Responsible Party: Brett Glotzbecker, MD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT02919670 History of Changes
• Other Study ID Numbers: 16-329
• First Posted: September 29, 2016
• Last Update Posted: May 3, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Brett Glotzbecker, Dana-Farber Cancer Institute:

Stem Cell Transplant

Additional relevant MeSH terms:

Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Melphalan; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs