MedTrace Logo

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

NCT04166565 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-04-20

No results posted yet for this study

Summary

This trial will try to establish the feasibility and efficacy of the combination of DaraVCD in Multiple Myeloma (MM) patients presenting with extramedullary disease (EMD). The study will be conducted as a Phase II trial.

Forty patients will be included in the study cohort. All patients will be followed closely for toxicities and response assessment. After completion of treatment, patients will be followed every 6 months for survival until 5 years after enrolment

Conditions

Interventions

DRUG

Daratumumab

Daratumumab 16 mg/kg will be administered by i.v. infusion. Daratumumab will be administered weekly in Cycles 1 and 2, then every 2 weeks for Cycles 3-6, and thereafter every month up to 36 months.

DRUG

Bortezomib

Bortezomib 1.5 mg/m2 bortezomib will be administered by a subcutaneous injection once weekly (Days 1, 8, 15 and 22) in all cycles.

DRUG

Cyclophosphamide

Cyclophosphamide 300 mg/m2 will be administered as a p.o. or i.v. weekly dose (Days 1, 8, 15, and 22) in every 28-day cycle (maximum weekly dose 500 mg). Dexamethasone will be administered on Days 1, 2, 8, 9, 15, 16, 22 and 23 in all cycles. On daratumumab infusion days dexamethasone may be administered i.v. or p.o. approximately 1 hour before the daratumumab infusion. On days when daratumumab is not administered, dexamethasone is to be administered p.o.

DRUG

Dexamethasone

Dexamethasone will be administered on Days 1, 2, 8, 9, 15, 16, 22 and 23 in all cycles. On daratumumab infusion days dexamethasone may be administered i.v. or p.o. approximately 1 hour before the daratumumab infusion. On days when daratumumab is not administered, dexamethasone is to be administered p.o.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Stichting European Myeloma Network

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Greece
  • Italy
  • Turkey (Türkiye)

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 NCT04166565 on ClinicalTrials.gov