Daratumumab in Treating Patients With Multiple Myeloma

NCT ID: NCT02944565

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2017-07-20

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.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (daratumumab)

Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: BIOLOGICAL

Given IV

Interventions

Daratumumab

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

Anti-CD38 Monoclonal Antibody; Darzalex; HuMax-CD38; JNJ-54767414

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Hofmeister, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2016-01504

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-16199

Identifier Type: -

Identifier Source: org_study_id