Trial Outcomes & Findings for Daratumumab in Treating Patients With Multiple Myeloma (NCT NCT02944565)

NCT ID: NCT02944565

Last Updated: 2019-09-09

Results Overview

The start and stop times of daratumumab infusion will be tracked during infusion acceleration.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2019-09-09

Participant Flow

Patients were enrolled beginning in February 2017 and patient enrollment was completed in June 2017

Participant milestones

Measure	Treatment (Daratumumab) Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daratumumab in Treating Patients With Multiple Myeloma

Baseline characteristics by cohort

Measure	Treatment (Daratumumab) n=28 Participants Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	28 patients n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

The start and stop times of daratumumab infusion will be tracked during infusion acceleration.

Outcome measures

Measure	Treatment (Daratumumab) n=28 Participants Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Total Daratumumab Infusion Time	1.5 hours Interval 1.5 to 2.4

SECONDARY outcome

Timeframe: Up to 6 months

Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.

Outcome measures

Measure	Treatment (Daratumumab) n=28 Participants Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)	0 Participants

SECONDARY outcome

Timeframe: Up to 6 months

IRR will be assessed during the first infusion using the accelerated dosing regimen. Number of patients who develop grade 3 or above IRR utilizing the accelerated infusion will be used for safety analysis.

Outcome measures

Measure	Treatment (Daratumumab) n=28 Participants Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Infusion-related Reactions (IRR)	0 participants with IRR

Adverse Events

Treatment (Daratumumab)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hallie Barr, PharmD BCOP

The Ohio State University Comprehensive Cancer Center

Phone: 614-685-5803

Email: Hallie.Barr@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place