Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 6, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2023

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide Pill

Lenalidomide will be administered PO on Days 1 through 21 of each 28 day cycle at the dose according to the frailty score and creatinine clearance.

DRUG

Dexamethasone

Dexamethasone will be administered at 20 mg per week. During weeks when the subject receives an infusion of daratumumab, dexamethasone will be administered on infusion days at a dose of 20 mg IV before the infusion.

DRUG

Daratumumab

Daratumumab (1800 mg) will be administered by SC injection by manual push over approximately 3 - 5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses. The volume of the SC solution will be 15 mL for the 1800 mg dose

Trial Locations (1)

46202

VA Roudebush Medical Center, Indianapolis

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

Indiana Institute for Medical Research

OTHER

lead

Attaya Suvannasankha

OTHER

NCT04223661 - Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy | Biotech Hunter | Biotech Hunter