Trial NCT06433947
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
- Phase
- Phase 1
- Sponsor
- Opna Bio LLC
- Conditions
- Relapsed Multiple Myeloma; Refractory Multiple Myeloma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 myelomaBrain metastases
* 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 yearsPrior malignancy
* Ongoing systemic infection requiring parenteral treatment
* Poorly controlled Type 2 diabetesDiabetes
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- DiabetesConditionalexclusionShow in the text
- Prior malignancyConditionalexclusion
disease-free for ≥3 years (other cancers); remission ≥2 years (Stage 1)
Show in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County