Multiple MyelomaNCT03276481
Prospective Evaluation of Taste Function In Multiple Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation
An observational study of Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Oral microbiota assessment, Comprehensive chemical gustometry and Measurement of salivary flow
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 12 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be identified by the Adult Bone Marrow Transplant team. They are usually identified in clinic when a treatment plan that includes conditioning chemotherapy has been scheduled.
Who may be able to join
- Age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age).
- Scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
- English or Spanish speaking
- Calculated creatinine clearance > 40 mL/min
Who cannot join
- Prior head and neck radiation.
- Severe periodontal infection. Poor oral hygiene and dentition as determined by pre HCT dental assessment.
- Pregnancy
- Patients with pre-existing moderate-severe dysgeusia
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Prospective Evaluation of Gustatory Function (Taste) In Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.
- Conditions
- Multiple Myeloma
- Being tested
- Oral microbiota assessment, Comprehensive chemical gustometry, Measurement of salivary flow, Surveys assessing taste disturbances
- Keywords
- melphalan, stem cell transplantation, 17-404, hematopoietic cell transplantation, HCT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral microbiota assessmentDiagnostic test
Whole mouth microbiota will be assessed by having participants swish in their mouth 10 ml of sterile water for 30 sec and then expectorate in a sterile container. Specimens will be immediately placed on wet ice and transferred to the laboratory for processing or for storage at -80° C until they are ready to be prepared for sequencing.
Comprehensive chemical gustometryDiagnostic test
Chemical gustometry assessments will be performed by a trained clinician on the study team, including a Registered Dietitian, Physician's Assistant, or Research Nurse. The test solutions and gradients will be formulated in house using sterile water and the following constituents: Sweet taste; 0.05, 0.1, and 0.2 g/ml sucrose, sour taste; 0.05, 0.09, and 0.165 g/ml citric acid, salty taste; 0.016, 0.04, and 0.1 g/ml NaCl and bitter taste; 0.0004, 0.0009, and 0.0024g/ml quinine-HCl. Umami will be tested with MSG at 25, 50, and 75 mM.
Measurement of salivary flowDiagnostic test
Both stimulated and un-stimulated salivation will be assessed by saliva collection in pre-weighed plastic containers. Participants will be seated with their back at a 90 degree angle and asked to swallow everything in their mouth. They will then be asked not to swallow and spit the accumulated saliva in the plastic container every 30 seconds for two minutes (unstimulated flow). For measurement of stimulated saliva, we will follow the same procedure except that after the initial swallow, participants will have their tongue swabbed twice with a cotton swab dipped in ascorbic acid solution or lemon juice.
Surveys assessing taste disturbancesBehavioural
Surveys will be administered and examine taste disturbances pre and post HCT.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma | Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen Receives: Diagnostic Test: Oral microbiota assessment; Diagnostic Test: Comprehensive chemical gustometry; Diagnostic Test: Measurement of salivary flow; Behavioral: Surveys assessing taste disturbances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT
The primary objective of this protocol is to evaluate the feasibility of comprehensive chemical gustometry in participants with MM undergoing autologous HCT. Chemical gustometry will be evaluated at baseline and on days -1, 7, 14, 30 and 100.
Measured: Change from baseline assessment up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start28 Aug 2017
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Giralt, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276481
- Sponsor's protocol ID
- 17-404
- Status last verified
- Jul 2023
- First submitted
- 6 Sep 2017
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Gustatory Function (Taste) In Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03276481
- Acronym / sponsor ID
- 17-404
- Conditions
- Multiple Myeloma
- Keywords
- melphalan, stem cell transplantation, 17-404, hematopoietic cell transplantation, HCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma | – | Diagnostic Test: Oral microbiota assessment, Diagnostic Test: Comprehensive chemical gustometry, Diagnostic Test: Measurement of salivary flow, Behavioral: Surveys assessing taste disturbancesParticipants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be identified by the Adult Bone Marrow Transplant team. They are usually identified in clinic when a treatment plan that includes conditioning chemotherapy has been scheduled.
Key inclusion criteria (4 listed)
- Age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age).
- Scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
- English or Spanish speaking
- Calculated creatinine clearance > 40 mL/min
Key exclusion criteria (4 listed)
- Prior head and neck radiation.
- Severe periodontal infection. Poor oral hygiene and dentition as determined by pre HCT dental assessment.
- Pregnancy
- Patients with pre-existing moderate-severe dysgeusia
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 |
|---|---|---|
| Oral microbiota assessmentWhole mouth microbiota will be assessed by having participants swish in their mouth 10 ml of sterile water for 30 sec and then expectorate in a sterile container. Specimens will be immediately placed on wet ice and transferred to the laboratory for processing or for storage at -80° C until they are ready to be prepared for sequencing. | Diagnostic test | Multiple Myeloma |
| Comprehensive chemical gustometryChemical gustometry assessments will be performed by a trained clinician on the study team, including a Registered Dietitian, Physician's Assistant, or Research Nurse. The test solutions and gradients will be formulated in house using sterile water and the following constituents: Sweet taste; 0.05, 0.1, and 0.2 g/ml sucrose, sour taste; 0.05, 0.09, and 0.165 g/ml citric acid, salty taste; 0.016, 0.04, and 0.1 g/ml NaCl and bitter taste; 0.0004, 0.0009, and 0.0024g/ml quinine-HCl. Umami will be tested with MSG at 25, 50, and 75 mM. | Diagnostic test | Multiple Myeloma |
| Measurement of salivary flowBoth stimulated and un-stimulated salivation will be assessed by saliva collection in pre-weighed plastic containers. Participants will be seated with their back at a 90 degree angle and asked to swallow everything in their mouth. They will then be asked not to swallow and spit the accumulated saliva in the plastic container every 30 seconds for two minutes (unstimulated flow). For measurement of stimulated saliva, we will follow the same procedure except that after the initial swallow, participants will have their tongue swabbed twice with a cotton swab dipped in ascorbic acid solution or lemon juice. | Diagnostic test | Multiple Myeloma |
| Surveys assessing taste disturbancesSurveys will be administered and examine taste disturbances pre and post HCT. | Behavioural | Multiple Myeloma |
Primary outcome
Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT
Time frame: Change from baseline assessment up to 100 days
The primary objective of this protocol is to evaluate the feasibility of comprehensive chemical gustometry in participants with MM undergoing autologous HCT. Chemical gustometry will be evaluated at baseline and on days -1, 7, 14, 30 and 100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sergio Giralt, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center 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 4 inclusion and 4 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 14 Jul 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT (time frame: Change from baseline assessment up to 100 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 14 Jul 2023.