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Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma

NCT03475628 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-03-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects of daratumumab monotherapy on bone disease in patients with relapsed/refractory MM who have received at least 2 prior lines of therapy, including lenalidomide and a PI.

Conditions

Interventions

DRUG

Daratumumab

Daratumumab will be given at a dose of 16 mg/kg administered as an 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 will receive pre-infusion medications prior to Daratumumab infusion to mitigate potential IRRs and post- infusion medications after Daratumumab infusion for the prevention of delayed IRRs

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Hellenic Society of Hematology

    lead OTHER

Principal Investigators

  • Evangelos Terpos, Assoc Prof · Department of Clinical therapeutics, National and Kapodistrian University of Athens, School of medicine, Athens, Greece

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-06-20
Completion
2020-02-20

Countries

  • Greece

Study Locations

More Related Trials

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 NCT03475628 on ClinicalTrials.gov