Spots Global Cancer Trial Database for Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy
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Trial Identification
Brief Title: Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy
Official Title: Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)
Study ID: NCT04223661
Conditions
Study Description
Brief Summary: The purpose of this study is to determine if using a subject's baseline frailty score to guide the dosing of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite).
Detailed Description: This is a multi-institution, prospective, single arm Phase II trial of lenalidomide in a combination with dexamethasone and daratumumab (DRd lite) with no blinding or randomization. This study will enroll 44 patients over 36 months. Primary Objectives: 1. Evaluate Response rate 2. Evaluate Side effects Secondary Objectives: 1. Evaluate Time on therapy 2. Evaluate Progression free survival 3. Evaluate Time to the next line of therapy 4. Assess Quality of life
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
VA Roudebush Medical Center, Indianapolis, Indiana, United States
Contact Details
Name: Attaya Suvannasankha, MD
Affiliation: Indiana University
Role: PRINCIPAL_INVESTIGATOR
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