NCT03450057

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hellenic Society of Hematology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, single arm, open-label phase 2 study. 38 subjects were enrolled to receive daratumumab and dexamethasone. Treatment cycles had a duration of 28 days. Subjects received treatment until either disease progression, death, unacceptable toxicity or for a maximum of 30 months. Drug administration and follow-up visits occurred more frequently for early cycles (weekly for the first 8 weeks, every two weeks for weeks 9-24 and then every 4 weeks). Disease evaluations occurred monthly and involved mainly measurements of myeloma proteins. Other assessments included bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and β2- microglobulin and albumin.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab with dexamethasone	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.

Timeline

• Start date: 2018-02-15
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2018-03-01
• Last updated: 2024-03-29
• Results posted: 2023-08-28

Locations

1 site across 1 country: Greece