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

Completed

• Conditions: Multiple Myeloma
• Interventions: Diagnostic Test: Oral microbiota assessment; Diagnostic Test: Comprehensive chemical gustometry; Diagnostic Test: Measurement of salivary flow; Behavioral: Surveys assessing taste disturbances

• Registration Number: NCT03276481
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Status Verified: 2023-07
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma	Oral microbiota assessment	Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen
Multiple Myeloma	Comprehensive chemical gustometry	Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen
Multiple Myeloma	Measurement of salivary flow	Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen
Multiple Myeloma	Surveys assessing taste disturbances	Participants with multiple myeloma undergoing autologous hematopoietic cell transplantation (HCT) after a high dose melphalan conditioning regimen

Primary Outcome Measures

Name	Time	Method
Feasibility of comprehensive chemical gustometry in participants with multiple myeloma undergoing autologous HCT	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States