Daratumumab in Treating Patients With Multiple Myeloma

Phase 2

Completed

• Conditions: Plasma Cell Myeloma
• Interventions: Biological: Daratumumab

• Registration Number: NCT02944565
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Study Start: 2017-02-22
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Results First Submitted: 2019-02-15
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (daratumumab)	Daratumumab	Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States