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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Attaya Suvannasankha
Study ID
NCT04223661
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide Pill — DRUG
    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.
  • Dexamethasone — DRUG
    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.
  • Daratumumab — DRUG
    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

Study Details

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).

Key Dates

Start date
Dec 6, 2021
Status verified
Dec 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Frailty score 1
    Starting dose of lenalidomide in subjects who are intermediately fit (frailty score of 1) will be 10 mg day 1-21 of 28 day cycle and escalate to 15 mg All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial.
  • Experimental: Frailty Score 2 or above
    Starting dose of lenalidomide in frail subjects (frailty score of 2 or higher) will be 5 mg day 1-21 of 28 day cycle, and escalate to 10 mg. All subjects will receive 20mg Dexamathasone weekly (split dosing is allowed) and 16mg Daratumumab (cycle 1-2 on days 1,8,15 and 22. Cycles 3-6 on days 1 and 15. Cycle 7 and beyond on day 1) during the course of the trial.

Primary Outcome Measure

Response Rate [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Roudebush Medical CenterIndianapolisIndiana46202-

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