Daratumumab in Treating Patients With Multiple Myeloma
Daratumumab Infusion Acceleration
2 other identifiers
interventional
28
1 country
1
Brief Summary
This phase II trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2017
CompletedResults Posted
Study results publicly available
September 9, 2019
CompletedSeptember 9, 2019
August 1, 2019
5 months
October 24, 2016
February 15, 2019
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Total Daratumumab Infusion Time
The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
Up to 6 months
Secondary Outcomes (2)
Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Up to 6 months
Infusion-related Reactions (IRR)
Up to 6 months
Study Arms (1)
Treatment (daratumumab)
EXPERIMENTALPatients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have received \>= 2 daratumumab infusions and be scheduled to receive another dose
- All races and ethnic groups are eligible for this study
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
- Prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hallie Barr, PharmD BCOP
- Organization
- The Ohio State University Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Craig Hofmeister, MD
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 26, 2016
Study Start
February 22, 2017
Primary Completion
July 20, 2017
Study Completion
July 20, 2017
Last Updated
September 9, 2019
Results First Posted
September 9, 2019
Record last verified: 2019-08