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Daratumumab in Treating Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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)
Hide 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
Arm/Group Title Treatment (Daratumumab)
Hide 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
Hide 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
1.Primary Outcome
Title Total Daratumumab Infusion Time
Hide Description The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Daratumumab)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Daratumumab)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Daratumumab)
Hide 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
Time Frame Adverse events were collected at the day of infusion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Daratumumab)
Hide 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%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Daratumumab)
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Daratumumab)
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hallie Barr, PharmD BCOP
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-685-5803
EMail: Hallie.Barr@osumc.edu
Layout table for additonal information
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