Phase 2
Completed N=28
Daratumumab in Treating Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT02944565 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Total Daratumumab Infusion Time — 1.5 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Daratumumab Infusion Time |
1.5 | — |
| SECONDARY Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE) |
— | — |
| SECONDARY Infusion-related Reactions (IRR) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02944565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.