NCT04223661

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

Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy in Elderly, Frail Newly Diagnosed Myeloma (MMY2035)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Attaya Suvannasankha · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-01-10
• Last updated: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study