Clinical trial NCT04649073: Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma (MM)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Phase1: Dose Limiting Toxicity
timeFrame: Day1~Day28
measure: Phase2: Response rate
timeFrame: Day1~Day366
Secondary outcomes:
Other outcomes:
Locations:
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
city: Okayama-shi
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Nobuhito Sanada
role: STUDY_DIRECTOR
References: