CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Daratumumab with dexamethasonedrug
Likely dose
Daratumumab with dexamethasone 16 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03450057
NCT03450057Phase 2Completed
CompareCT.gov

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment

Hellenic Society of Hematology·interventional·Posted Mar 1, 2018·Updated Mar 29, 2024

In Brief

A Phase 2 clinical trial evaluating Daratumumab with dexamethasone for Relapsed/Refractory Multiple Myeloma. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate the effects of daratumumab with dexamethasone (DaraD) in subjects with relapsed or refractory multiple myeloma and renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory Multiple Myeloma
CountriesGreece
CollaboratorsJanssen Pharmaceuticals

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartFeb 15, 2018
Primary CompletionMar 22, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.3 years ago

Interventions

Daratumumab with dexamethasonedrug

Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \>75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.