Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT02331368
Eligibility Criteria:
Inclusion Criteria:
* Subjects with MM (Multiple Myeloma) of any stage
* Has no Progressive Disease (PD) AND has suboptimal response with primary therapy
* Has measurable disease
* Has no prior hematopoietic stem cell transplant of any type
* Has performance status of 0 or 1 (Eastern Cooperative Oncology, ECOG, Performance Scale)
* Has had a successful peripheral blood stem cell collection with G-CSF (Filgrastim) +/- Plerixafor (Mozobil) only
* Be willing and able to provide written informed consent
* Female subjects of child bearing age should have negative urine or serum pregnancy test
* Female subjects of child bearing age must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity
* Male subjects must agree to use an adequate method of contraception
* Subject must be able to swallow capsules
* Must demonstrate adequate organ function
Exclusion Criteria:
* Has history of repeat infections, amyloidosis, hyperviscosity, plasma cell leukemia, POEMS syndrome, Waldenstrom's macroglobulinemia, non-secretory multiple myeloma, or IgM myeloma
* Has known CNS (Central Nervous System) involvement or history of resolved CNS involvement
* Has an active autoimmune disease or history of autoimmune disease that requires systemic treatment with steroids of immunosuppressive agents.
* Has active, non-infectious pneumonitis
* Has diagnosis of immunosuppressive disorder or on immunosuppressive therapy within 7 days of transplant admission
* Is currently participating in or has previously participated in the study of an investigational drug/device within 4 weeks of transplant admission
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4
* Has had prior monoclonal antibody, chemotherapy, small molecule therapy, or radiation within 2 weeks of transplant admission
* Has not recovered from adverse events due to previously administered agent
* Must be free of additional malignancy for at least 5 years
* Has an active infection requiring systemic therapy
* Has known psychiatric or substance abuse disorders that would interfere with requirements of the study
* Is pregnant or breastfeeding or expecting to conceive
* Has known HIV, Hepatitis B, or Hepatitis C infection
* Has clinically significant coagulopathy
* Has known symptomatic heart failure, unstable angina pectoris, or cardiac arrhythmia
* Has received any type of hematopoietic cell transplant
* Has received a live vaccine within 30 days of transplant admission
* Is or has an immediate family member whos is investigational site or sponsor staff directly involved with this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02331368
Study Brief:
Protocol Section:
NCT02331368