NCT02944565 · REGISTRY CONDITION SEARCH

Daratumumab in Treating Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-09-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Total Daratumumab Infusion Time

→

outcome · POSTED

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

→

outcome · POSTED

Infusion-related Reactions (IRR)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
intervention Names
Biological: Daratumumab
label
Treatment (daratumumab)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (daratumumab)
description
Given IV
name
Daratumumab
other Names
Anti-CD38 Monoclonal Antibody
Darzalex
HuMax-CD38
JNJ-54767414
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 28
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

description
Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.
measure
Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
time Frame
Up to 6 months
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.
measure
Infusion-related Reactions (IRR)
time Frame
Up to 6 months

Full 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.
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.

Source references