Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396496
Other study ID # 207442
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 22, 2020
Est. completion date October 16, 2023

Study information

Verified date October 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial investigates the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with Polyneuropathy, Organomegaly, Endocrinopathy, m Protein Component, Skin Changes (POEMS) syndrome. This trial will enroll ten subjects, who will complete 12 four-week cycles of DARA, in combination with the immunomodulatory drug (IMiD) lenalidomide. Objectives of this study include improvement in neuropathy and performance status, as well as improvement in laboratory values and survival.


Description:

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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Success There is a one-point improvement in ECOG performance score; and/or = 50% reduction in ONLS score at Day 360. 360 days
See also
  Status Clinical Trial Phase
Recruiting NCT06040567 - Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Recruiting NCT05263817 - A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis Early Phase 1
Active, not recruiting NCT02921893 - Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome Early Phase 1
Completed NCT01816620 - Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome Phase 2
Completed NCT02193698 - Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial Phase 2
Completed NCT01639898 - POEMS Syndrome Treatment With Lenalidomide Phase 2
Recruiting NCT00971685 - The Treatment of Lenalidomide in Patients With POEMS Syndrome Phase 2
Recruiting NCT05476458 - To Evaluate Efficacy of Red Dichromatic Imaging (RDI) in Achieving Hemostasis During POEM Using GF 1500 UGI Scope