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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649073
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma (MM) Biological: OPC-415 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Uncontrolled, Nonrandomized, Open-Label, Phase 1/2 Trial Investigating the Safety and Efficacy of OPC 415 in MMG49 Antigen-Positive Patients With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2041

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: OPC-415 (up to 1×10^7cells/kg) Biological: OPC-415
OPC-415 (up to 1×10^7cells/kg) On 2 days


Outcome Measures
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Primary Outcome Measures :
  1. Phase1: Dose Limiting Toxicity [ Time Frame: Day1~Day28 ]
  2. Phase2: Response rate [ Time Frame: Day1~Day366 ]
    The proportion of subjects who achieved partial response or better outcomes by central assessment based on IMWG Uniform Response Criteria for Multiple Myeloma will be calculated.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649073


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Tokai University Hospital Recruiting
Isehara-shi, Japan
National Hospital Organization Okayama Medical Center Not yet recruiting
Okayama-shi, Japan
Tohoku University Hospital Recruiting
Sendai-shi, Japan
Japanese Red Cross Medical Center Recruiting
Shibuya-ku, Japan
Osaka University Hospital Recruiting
Suita-shi, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Nobuhito Sanada Otsuka Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04649073    
Other Study ID Numbers: 415-102-00001
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: :The focus of this study is a rare disease.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases