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
- Are there results?
- None posted in the registry
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.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04649073
- Acronym / sponsor ID
- 415-102-00001
- Conditions
- Multiple Myeloma (MM)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPC-415 (up to 1×10^7cells/kg) | Experimental | Biological: OPC-415 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-415OPC-415 (up to 1×10^7cells/kg) On 2 days | Biological | OPC-415 (up to 1×10^7cells/kg) |
Primary outcome
Phase1: Dose Limiting Toxicity
Time frame: Day1~Day28
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.
Results and safety
The study was stopped early (reason given: This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. :The focus of this study is a rare disease.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobuhito Sanada study director
Otsuka Pharmaceutical Co., Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase1: Dose Limiting Toxicity (time frame: Day1~Day28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.