Treatment of POEMS Syndrome With Daratumumab (NCT04396496) | Clinical Trial Compass
CompletedPhase 2
Treatment of POEMS Syndrome With Daratumumab
United States2 participantsStarted 2020-09-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have POEMS syndrome and meet the diagnostic criteria for POEMS syndrome as described in Appendix I.
* Both newly-diagnosed and relapsed POEMS syndrome will be eligible for inclusion.
* Patients must have a platelet count of ≥ 50,000/μL.
* Patients must be at least 18 years of age.
* Participants must have preserved renal function as defined by a serum creatinine level of \< 3 mg/dL.
* Participants must have an ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) scan ≥ 40 percent.
* Eastern Cooperative Oncology Group ≥ 1,
* Overall Neuropathy Limitations Scale (ONLS) ≥ 1.
* Patients must have signed an institutional review board (IRB)-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.
Exclusion Criteria:
* Documented allergy to lenalidomide, DARA, mannitol, other monoclonal antibodies or human proteins and mammalian-derived products.
* Prior treatment with DARA or other CD38 monoclonal antibodies
* Patients with central nervous system (CNS) Multiple Myeloma (MM) involvement.
* Patients who have received an investigational drug or device within 4 weeks prior to enrollment or received live attenuated vaccine within 4 weeks prior to enrollment.
* Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment accor…