Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Opna Bio LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed diagnosis of multiple myeloma (MM)
Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
Adequate hematologic, renal, liver, cardiac function
You may not be if
Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
Active plasma cell leukemia
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
Prior Stevens Johnson syndrome
Localized radiation therapy to disease site(s) within 2 weeks of the first dose
Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug
Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.
Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
Known central nervous system involvement by multiple myeloma
Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years
