RecruitingRelapsed Multiple MyelomaRefractory Multiple Myeloma

Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.

Sponsor: Opna Bio LLC

You may qualify 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 qualify 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