Multiple MyelomaNCT02919670
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 study testing Enterade and Standard Supportive Care in people with Multiple Myeloma and Non-Hodgkin's Lymphoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Non-Hodgkin's Lymphoma
- What is being tested?
- Enterade and Standard Supportive Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma, Non-Hodgkin's Lymphoma
- Being tested
- Enterade, Placebo, Standard Supportive Care
- Keywords
- Stem Cell Transplant
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteradeDietary supplement
PlaceboDietary supplement
Standard Supportive CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo; Other: Standard Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (8)
Maximum Daily Stool Frequency
Measured: 14 days
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Measured: 14 days
Duration Of Hospitalization (Days) From Admission To Discharge
Measured: Up to 45 days
Percent Change in Weight From Baseline to Day 14
Measured: baseline and day 14
Median Amount Of Anti-Diarrheal Medications
Measured: 14 days
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
Measured: 14 days
Calorie Consumption
Measured: 14 days
Number of Participants With Fever or Neutropenia
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Entrinsic Health
- Responsible party
- Principal investigator, Mahasweta Gooptu, Dana-Farber Cancer Institute
- Investigators
- Mahasweta Gooptu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919670
- Sponsor's protocol ID
- 16-329
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2016
- Last updated
- 16 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02919670
- Acronym / sponsor ID
- 16-329
- Conditions
- Multiple Myeloma, Non-Hodgkin's Lymphoma
- Keywords
- Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Entrinsic Health
- Study start
- Oct 2016
- Primary completion
- May 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 16 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enterade and Standard Supportive Care | Experimental | Dietary Supplement: Enterade, Other: 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 |
| Placebo and Standard Supportive Care | Placebo comparator | Dietary Supplement: Placebo, Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
Time frame: 14 days
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
8 secondary outcomes
Maximum Daily Stool Frequency
Time frame: 14 days
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Time frame: 14 days
Duration Of Hospitalization (Days) From Admission To Discharge
Time frame: Up to 45 days
Percent Change in Weight From Baseline to Day 14
Time frame: baseline and day 14
Median Amount Of Anti-Diarrheal Medications
Time frame: 14 days
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
Time frame: 14 days
Calorie Consumption
Time frame: 14 days
Number of Participants With Fever or Neutropenia
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahasweta Gooptu, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterade and Standard Supportive Care in people with Multiple Myeloma and Non-Hodgkin's Lymphoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.