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Trial record 3 of 19 for:    hofmeister

Daratumumab in Treating Patients With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02944565
First received: October 24, 2016
Last updated: April 18, 2017
Last verified: April 2017

October 24, 2016
April 18, 2017
February 22, 2017
May 31, 2019   (Final data collection date for primary outcome measure)
Safety and tolerability of decreased infusion time for Daratumumab [ Time Frame: Up to 24 months ]
The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
  • Accelerated infusion time [ Time Frame: Up to 24 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 24 months ]
  • Infusion-related reactions (IRR) defined and calculated as the number of patients with grade 3 IRR divided by the total number of patients who receive the accelerated dosing regimen according to CTCAE [ Time Frame: Up to 24 months ]
  • Number of daratumumab infusions [ Time Frame: Up to 24 months ]
    Will be tracked from the time of consent until the last daratumumab infusion.
Complete list of historical versions of study NCT02944565 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events defined as grade 3-4 reactions assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 24 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 24 months ]
    IRR will be assessed with the first dose using the accelerated doing regimen. The incidence rate of IRR is defined and calculated as the number of patients with grade 3 IRR divided by the total number of patients who receive the accelerated dosing regimen.
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Daratumumab in Treating Patients With Multiple Myeloma
Daratumumab Infusion Acceleration
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.

PRIMARY OBJECTIVES:

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.

OUTLINE:

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Plasma Cell Myeloma
Biological: Daratumumab
Given IV
Other Names:
  • Anti-CD38 Monoclonal Antibody
  • Darzalex
  • HuMax-CD38
  • JNJ-54767414
Experimental: Treatment (daratumumab)
Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention: Biological: Daratumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
May 31, 2020
May 31, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCCClinicaltrials@osumc.edu
Contact: Hallie Barr 614-685-5803 Hallie.Barr@osumc.edu
United States
 
 
NCT02944565
OSU-16199
NCI-2016-01504 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Craig Hofmeister, MD Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP