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A Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma

NCT03697629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-15

No results posted yet for this study

Summary

Primary objective: To determine the incidence of infusion related reactions (IRR's) in the first 6 months of daratumumab administration.

Conditions

  • Multiple Myeloma in Relapse

Interventions

DRUG

Daratumumab

Patients will receive daratumumab, in the following schedule: Daratumumab 8mg/kg in 500 mL over 4 hours Cycle 1 Day 1, Daratumumab 16mg/kg in 500 mL over 90 minutes (20% of dose given in first 30 minutes and remaining 80% of dose given over 60 minutes) Cycle 1 Days 8, 15 and 22; Cycle 2 Days 1, 8, 15, and 22, and on Days 1 and 15 for Cycles 3-6.

Sponsors & Collaborators

  • Canadian Myeloma Research Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2020-07-21
Completion
2021-12-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03697629 on ClinicalTrials.gov