Daratumumab in Treating Patients With Multiple Myeloma

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02944565
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plasma Cell Myeloma	Biological: Daratumumab	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Daratumumab Infusion Acceleration
• Actual Study Start Date: Feb 22, 2017
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Jul 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (daratumumab) Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.	Biological: Daratumumab; Given IV; Other Names: Anti-CD38 Monoclonal Antibody Darzalex HuMax-CD38 JNJ-54767414

Outcome Measures

Primary Outcome Measures

1. Total Daratumumab Infusion Time [Up to 6 months]

   The start and stop times of daratumumab infusion will be tracked during infusion acceleration.

Secondary Outcome Measures

1. Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE) [Up to 6 months]

   Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.

2. Infusion-related Reactions (IRR) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Craig Hofmeister, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2017

More Information

Additional Information:

• Jamesline

Publications

None provided.

• Responsible Party: Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02944565
• Other Study ID Numbers: OSU-16199; NCI-2016-01504
• First Posted: Oct 26, 2016
• Last Update Posted: Sep 9, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Daratumumab

Study Results

Participant Flow

Recruitment Details	Patients were enrolled beginning in February 2017 and patient enrollment was completed in June 2017

Arm/Group Title	Treatment (Daratumumab)
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

Baseline Characteristics

Arm/Group Title	Treatment (Daratumumab)
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 Participants	28
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	9 32.1%
Male	19 67.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 10.7%
White	24 85.7%
More than one race	0 0%
Unknown or Not Reported	1 3.6%
Region of Enrollment (patients) [Number]
United States	28

Outcome Measures

1. Primary Outcome

Title	Total Daratumumab Infusion Time
Description	The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
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.
Measure Participants	28
Median (Full Range) [hours]	1.5

2. Secondary Outcome

Title	Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
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
Measure Participants	28
Count of Participants [Participants]	0 0%

3. Secondary Outcome

Title	Infusion-related Reactions (IRR)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Daratumumab)
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.
Measure Participants	28
Number [participants with IRR]	0 0%

Adverse Events

Time Frame	Adverse events were collected at the day of infusion
Arm/Group Title	Treatment (Daratumumab)
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 (%)	# Events
Total	0/28 (0%)
Serious Adverse Events
	Treatment (Daratumumab)
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Daratumumab)
	Affected / at Risk (%)	# Events
Total	0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.