Daratumumab in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02944565|
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Biological: Daratumumab||Phase 2|
I. Determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab.
II. Estimate the time savings versus (vs) predicted infusion time.
Patients receive daratumumab intravenously (IV) over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Daratumumab Infusion Acceleration|
|Actual Study Start Date :||February 22, 2017|
|Actual Primary Completion Date :||July 20, 2017|
|Actual Study Completion Date :||July 20, 2017|
Experimental: Treatment (daratumumab)
Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Total Daratumumab Infusion Time [ Time Frame: Up to 6 months ]The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
- Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 6 months ]Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.
- Infusion-related Reactions (IRR) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944565
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Craig Hofmeister, MD||Ohio State University Comprehensive Cancer Center|