Treatment of POEMS Syndrome With Daratumumab
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|ClinicalTrials.gov Identifier: NCT04396496|
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : August 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|POEMS Syndrome||Drug: Daratumumab Injection||Phase 2|
This trial investigates the use of DARA, an antibody directed at the human CD38 molecule, for the treatment of patients with POEMS syndrome. This trial will enroll ten subjects, who will complete 12 four-week cycles of DARA, in combination with the IMiD lenalidomide. Objectives of this study include improvement in neuropathy and performance status, as well as improvement in laboratory values and survival.
Patients will receive DARA in the outpatient setting, with infusions being administered in Infusion 4. Safety and response assessments will occur prior to Cycles 1 through 6, and at the end of DARA treatment. Once DARA is completed, response assessments are completed every 6 months for the first year, then annually until disease progression. Subjects will also be followed for overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial for the Treatment of POEMS Syndrome With Daratumumab|
|Actual Study Start Date :||September 22, 2020|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2030|
Experimental: Daratumumab Injection
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Drug: Daratumumab Injection
DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
Other Name: Darzalex
- Treatment Success [ Time Frame: 360 days ]There is a one-point improvement in ECOG performance score; and/or ≥ 50% reduction in ONLS score at Day 360.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396496
|Contact: Robert Smithfirstname.lastname@example.org|
|Contact: Matthew Kovak, MSemail@example.com|
|United States, Arkansas|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Matthew Kovak 501-686-8274 firstname.lastname@example.org|
|Principal Investigator:||Frits van Rhee, MD||University of Arkansas|