Daratumumab in Treating Patients With Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT02944565
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Results First Posted: September 9, 2019
• Last Update Posted: September 9, 2019
• Sponsor: Ohio State University Comprehensive Cancer Center
• Information provided by (Responsible Party): Ohio State University Comprehensive Cancer Center

• Study Type: Interventional
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Plasma Cell Myeloma
• Intervention: Biological: Daratumumab
• Enrollment: 28

Participant Flow

Recruitment Details	Patients were enrolled beginning in February 2017 and patient enrollment was completed in June 2017
Pre-assignment Details

Arm/Group Title	Treatment (Daratumumab)
Arm/Group Description	Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started	28
Completed	28
Not Completed	0

Baseline Characteristics

Arm/Group Title		Treatment (Daratumumab)
Arm/Group Description		Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants		28
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	28 participants
		67; (44 to 90)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	Female	9 32.1%
	Male	19 67.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 10.7%
	White	24 85.7%
	More than one race	0 0.0%
	Unknown or Not Reported	1 3.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Patients
United States	Number Analyzed	28 participants
		28

Outcome Measures

1. Primary Outcome

Title	Total Daratumumab Infusion Time
Description	The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
Arm/Group Description:	Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	28
Median (Full Range); Unit of Measure: hours
	1.5; (1.5 to 2.4)

2. Secondary Outcome

Title	Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Description	Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
Arm/Group Description:	Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Overall Number of Participants Analyzed	28
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

3. Secondary Outcome

Title	Infusion-related Reactions (IRR)
Description	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.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
Arm/Group Description:	Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	28
Measure Type: Number; Unit of Measure: participants with IRR
	0

Adverse Events

Time Frame	Adverse events were collected at the day of infusion
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment (Daratumumab)
Arm/Group Description	Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
	Treatment (Daratumumab)
	Affected / at Risk (%)
Total	0/28 (0.00%)
Serious Adverse Events
	Treatment (Daratumumab)
	Affected / at Risk (%)
Total	0/28 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment (Daratumumab)
	Affected / at Risk (%)
Total	0/28 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Hallie Barr, PharmD BCOP
• Organization: The Ohio State University Comprehensive Cancer Center
• Phone: 614-685-5803
• EMail: Hallie.Barr@osumc.edu

• Responsible Party: Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02944565 History of Changes
• Other Study ID Numbers: OSU-16199; NCI-2016-01504 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Results First Submitted: February 15, 2019
• Results First Posted: September 9, 2019
• Last Update Posted: September 9, 2019