Multiple Myeloma (MM)Phase 1/2NCT04649073
Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1/2 study testing OPC-415 in people with Multiple Myeloma (MM), run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- OPC-415
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 8 sitesJapan
- Study dates
- 18 Feb 2021to 9 Apr 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Tokai University Hospital
Isehara-shi
Nagoya City University Hospital
Nagoya
National Hospital Organization Okayama Medical Center
Okayama
Sapporo Medical University Hospital
Sapporo
Tohoku University Hospital
Sendai
Japanese Red Cross Medical Center
Shibuya-ku
Osaka University Hospital
Suita-shi
Yamagata University Hospital
Yamagata
About this study
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
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).
- Conditions
- Multiple Myeloma (MM)
- Being tested
- OPC-415
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-415Biological
OPC-415 (up to 1×10^7cells/kg) On 2 days
| Study group | Role | What they receive |
|---|---|---|
| OPC-415 (up to 1×10^7cells/kg) | Experimental | Not described Receives: Biological: OPC-415 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase1: Dose Limiting Toxicity
Measured: Day1~Day28
Phase2: Response rate
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.
Measured: Day1~Day366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start18 Feb 2021
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Why it stopped: This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649073
- Sponsor's protocol ID
- 415-102-00001
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: :The focus of this study is a rare disease.