Prospective Evaluation of Taste Function In Multiple Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation

NCT03276481 | Completed

• 1 other identifier: 17-404
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.

Conditions

Multiple Myeloma

Keywords

melphalan; stem cell transplantation; 17-404; hematopoietic cell transplantation; HCT

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline assessment up to 100 days

Study Arms (1)

Multiple Myeloma

Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen

Diagnostic Test: Oral microbiota assessment; Diagnostic Test: Comprehensive chemical gustometry; Diagnostic Test: Measurement of salivary flow; Behavioral: Surveys assessing taste disturbances

Interventions

Oral microbiota assessment DIAGNOSTIC_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.

Multiple Myeloma

Comprehensive chemical gustometry DIAGNOSTIC_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.

Multiple Myeloma

Measurement of salivary flow DIAGNOSTIC_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.

Multiple Myeloma

Surveys assessing taste disturbances BEHAVIORAL

Surveys will be administered and examine taste disturbances pre and post HCT.

Multiple Myeloma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Sergio Giralt, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: August 28, 2017
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

US (1)