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

Sponsor
Canadian Myeloma Research Group
Study ID
NCT03697629
Phase
PHASE2
Status
Completed

Conditions

  • Multiple Myeloma in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Dec 3, 2018
Status verified
Feb 2022
Primary completion
Jul 21, 2020
Completion
Dec 20, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Increased infusion rate daratumumab monotherapy

Primary Outcome Measure

Incidence of infusion related reactions (IRRs) [ Time Frame: First 6 months of daratumumab administration ]

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