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Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma

Recruiting
20 - 80 years of age
Both
Phase 1/2

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Overview

The purpose of this study is to evaluate the tolerability,safety and efficacy of OPC-415 in patients with relapsed and/or refractory Multiple Myeloma (MM).

Eligibility

Inclusion Criteria:

  • Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at the time of consent
  • Patients with a definitive diagnosis of active multiple myeloma
  • Patients who have had 2 or more prior regimens (including all proteasome inhibitors, immunomodulators, and anti-CD38 antibody)
  • Patients with relapsed and/or refractory Multiple Myeloma
  • Patients who are positive for MMG49 antigen
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. Those with an ECOG-PS score of 2 due solely to MM bone lesions can be enrolled
  • Patients who are expected to survive for at least 3 months

Exclusion Criteria:

  • Patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment.
  • Patients who have other active double/multiple cancers
  • Patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents
  • Patients with graft-versus-host disease that requires treatment.
  • Patients who underwent a highly invasive and extensive surgical procedure within 2 weeks.
  • Patients who previously underwent allogeneic stem cell transplantation or organ transplantation.
  • Patients who underwent autologous stem cell transplantation within 90 days.
  • Patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia.
  • Patients with prior or current central nerve involvement in MM.
  • Patients whose best ever response to MM treatment is PD.
  • Patients who previously received gene therapy or cell therapy (except hematopoietic stem cell transplantation).
  • Pregnant women, nursing mothers, or women with a positive pregnancy test.

Study details

Multiple Myeloma (MM)

NCT04649073

Otsuka Pharmaceutical Co., Ltd.

28 January 2024

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