Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- Phase1: Dose Limiting Toxicity [Day1~Day28]
- Phase2: Response rate [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
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
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Patients who are positive for MMG49 antigen
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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:
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Patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment.
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Patients who have other active double/multiple cancers
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Patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents
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Patients with graft-versus-host disease that requires treatment.
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Patients who underwent a highly invasive and extensive surgical procedure within 2 weeks.
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Patients who previously underwent allogeneic stem cell transplantation or organ transplantation.
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Patients who underwent autologous stem cell transplantation within 90 days.
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Patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia.
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Patients with prior or current central nerve involvement in MM.
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Patients whose best ever response to MM treatment is PD.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tokai University Hospital | Isehara-shi | Japan | ||
| 2 | National Hospital Organization Okayama Medical Center | Okayama-shi | Japan | ||
| 3 | Tohoku University Hospital | Sendai-shi | Japan | ||
| 4 | Japanese Red Cross Medical Center | Shibuya-ku | Japan | ||
| 5 | Osaka University Hospital | Suita-shi | Japan |
Sponsors and Collaborators
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 415-102-00001