A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in ā¦ (NCT03374085) | Clinical Trial Compass
TerminatedPhase 1/2
A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Stopped: Business objectives have changed
United States200 participantsStarted 2018-02-06
Plain-language summary
This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM).
All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Subject is ā„ 18 years of age at the time of signing the informed consent form (ICF).
ā. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
ā. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
ā. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
ā. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:
ā. All subjects must have:
ā. Subjects must have the following laboratory values:
ā. Females of childbearing potential (FCBP) must:
Exclusion criteria
ā. Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
What they're measuring
1
Adverse Events (AEs)
Timeframe: From enrollment until at least 28 days after completion of study treatment
ā. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
ā. Subject has any condition that confounds the ability to interpret data from the study.
ā. Subject has non-secretory multiple myeloma.
ā. Subject has refractory primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen).
ā. Subject has plasma cell leukemia or active leptomeningeal myelomatosis.
ā. Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
ā. Subject has immunoglobulin class M (IgM) myeloma.