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

Last updated: August 5, 2024
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer

Platelet Disorders

Multiple Myeloma

Treatment

OPC-415

Clinical Study ID

NCT04649073
415-102-00001
  • Ages 20-80
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, atthe 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 canbe enrolled

  • Patients who are expected to survive for at least 3 months

Exclusion

Exclusion Criteria:

  • Patients who are scheduled to receive high-dose chemotherapy in combination withautologous stem cell transplantation as the next treatment.

  • Patients who have other active double/multiple cancers

  • Patients on continuous and systemic (oral or intravenous) medication withcorticosteroids or other immunosuppressive agents

  • Patients with graft-versus-host disease that requires treatment.

  • Patients who underwent a highly invasive and extensive surgical procedure within 2weeks.

  • Patients who previously underwent allogeneic stem cell transplantation or organtransplantation.

  • Patients who underwent autologous stem cell transplantation within 90 days.

  • Patients with systemic amyloidosis (except localized amyloidosis without organderangement) 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 hematopoieticstem cell transplantation).

  • Pregnant women, nursing mothers, or women with a positive pregnancy test.

Study Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: OPC-415
Phase: 1/2
Study Start date:
February 18, 2021
Estimated Completion Date:
January 31, 2041

Connect with a study center

  • Tokai University Hospital

    Isehara-shi,
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama-shi,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi,
    Japan

    Active - Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku,
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-shi,
    Japan

    Active - Recruiting

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