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

NCT04223661 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-08

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Indiana Institute for Medical Research

    collaborator OTHER

  • Attaya Suvannasankha

    lead OTHER

Principal Investigators

  • Attaya Suvannasankha, MD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223661 on ClinicalTrials.gov