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Trial record 3 of 18 for:    hofmeister

Daratumumab in Treating Patients With Multiple Myeloma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Ohio State University Comprehensive Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02944565
First received: October 24, 2016
Last updated: NA
Last verified: October 2016
History: No changes posted

October 24, 2016
October 24, 2016
January 2017
May 2017   (final data collection date for primary outcome measure)
  • Accelerated infusion time [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of daratumumab infusions [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Will be tracked from the time of consent until the last daratumumab infusion.
Same as current
No Changes Posted
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.
 
Not yet recruiting
28
Not Provided
May 2017   (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
Both
18 Years and older   (Adult, Senior)
No
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
United States
 
NCT02944565
OSU-16199, NCI-2016-01504, P30CA016058
Yes
Not Provided
Not Provided
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Craig Hofmeister Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
October 2016

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