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All Drugs and Chemicals

Melphalan

* 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

* 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

Enterade

Placebo

Standard Supportive Care

Mahasweta Gooptu, MD

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.

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.

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

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

Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention

Entrinsic Health

Dana-Farber Cancer Institute

Principal Investigator

The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT

* 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

Enterade 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

Placebo and Standard Supportive Care

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Count of participants

Kelly Masone

Only 17 participants met the protocol definition of compliance

Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity

Day +1 to Day +7

Day +8 to Day +14

Maximum Daily Stool Frequency

Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency

Duration Of Hospitalization (Days) From Admission To Discharge

Percent Change in Weight From Baseline to Day 14

Median Amount Of Anti-Diarrheal Medications

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Multiple Myelom... Non-Hodgkin's L...	Enterade Placebo Standard Suppor...	18 Years -	Dana-Farber Cancer Institute
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	Multiple Myelom... Non-Hodgkin's L...	Enterade Placebo Standard Suppor...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for enterade

Every month we try and update this database with for enterade cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for enterade

Every month we try and update this database with for enterade cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for enterade cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.