Daratumumab in Treating Patients With Multiple Myeloma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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