Daratumumab in Treating Patients With Multiple Myeloma
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/20/2017 |
| Start Date: | February 22, 2017 |
| End Date: | May 31, 2020 |
| Contact: | Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCCClinicaltrials@osumc.edu |
| Phone: | 800-293-5066 |
Daratumumab Infusion Acceleration
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.
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.
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.
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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Craig C. Hofmeister, MD
Phone: 614-293-7807
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