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

Launched by OPNA BIO LLC · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called OPN-6602 for patients with relapsed multiple myeloma, which means their cancer has come back after treatment, or refractory multiple myeloma, where the cancer has not responded well to treatment. The goal is to see how safe OPN-6602 is, how well it works, and how it behaves in the body. Participants may receive OPN-6602 alone or in combination with a medication called dexamethasone. The trial is currently looking for patients aged 65 to 74 who have already tried three different types of treatments for their multiple myeloma and did not benefit from them.

To be eligible for this trial, patients must have a confirmed diagnosis of multiple myeloma and meet certain health criteria, including having good blood, kidney, liver, and heart function. However, individuals with specific conditions, such as other types of blood cancers or those who have recently received certain treatments, may not qualify. Participants can expect regular check-ups to monitor their health and how the treatment is working. It's important to know that this is an early-stage trial, which means researchers are primarily focused on safety and how the body reacts to the new treatment.

Gender

ALL

Eligibility criteria

• 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 screening; 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
• • Ongoing systemic infection requiring parenteral treatment
• • Poorly controlled Type 2 diabetes