Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Mye… (NCT04835129) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
United States28 participantsStarted 2022-01-10
Plain-language summary
This is a multicenter, open-label phase II study in subjects with relapsed and/or refractory multiple myeloma with at least two prior lines of therapy. The main study consists of three phases: a 28-day screening phase, treatment phase that consists of 28-day cycles of isatuximab with elotuzumab, pomalidomide, and dexamethasone and a follow-up phase.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary consent must be given before performance of any study related procedure.
✓. Male or female subjects ≥18 years.
✓. Multiple myeloma subjects with at least 2 prior therapies that included lenalidomide and proteasome inhibitor combined or in different regimens, and refractory to most recent line of therapy.
✓. Measurable disease as defined by any of the following:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
✓. Female subjects who:
✓. Are postmenopausal (see Appendix 4 for definition) for at least one year before the screening visit, OR
✓. Are surgically sterile, OR
Exclusion criteria
✕. Diagnosed or treated for malignancy other than multiple myeloma, except:
✕. Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
✕. Prior cluster of differentiation 38 (CD38) monoclonal antibody is allowed as long it has been \>6 months and patients had achieved at least a partial response or better.
What they're measuring
1
The number of subjects in each status category of the International Myeloma Working Group (stringent complete response, complete response, very good partial response, partial response).
. Subject refractory or intolerant to prior pomalidomide therapy.
✕. Known chronic obstructive pulmonary disease
✕. Known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. Note: Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study.
✕. Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have untreated or active hepatitis C.