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New hope for Hard-to-Treat myeloma: teclistamab trial in japan

NCT ID NCT04696809

Disease control Sponsor: Janssen Pharmaceutical K.K. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested teclistamab, a drug that helps the immune system find and attack myeloma cells, in 40 Japanese patients whose multiple myeloma had returned or stopped responding to treatment. The goal was to check safety and find the right dose in phase 1, then see how well it works in phase 2. The trial is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teclistamab (a bispecific antibody that helps immune cells attack myeloma cells)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with multiple myeloma that has returned or not responded to other therapies.
What could go wrong
This is an early-phase trial with only 40 participants, so results may not apply to all patients. Side effects like cytokine release syndrome and other immune reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

40 people

The number who actually took part.

Started

Feb 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria * Participant must have measurable disease defined by any of the following: Serum M-protein level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); Urine M-protein level \>= 200 milligrams per 24 hours (mg/24 hours); or Light chain MM, for participants without measurable disease in the serum or urine: serum Ig-free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa-lambda FLC ratio; or if central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25 percent (%) * Participant must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant to established MM therapies and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitors (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody in any order during the course of treatment. Participants who could not tolerate PI, immunomodulatory drugs, or anti-CD38 antibody are allowed * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration * Woman of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (beta-human chorionic gonadotropin \[beta-hCG\]) or urine Exclusion criteria: * Prior treatment with any B cell maturation antigen (BCMA)-targeted therapy * Toxicities from previous anticancer therapies that have not resolved to baseline levels or to less than or equal to (\<=) Grade 1 except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication) * Stem cell transplantation: An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease; Received an autologous stem cell transplant less than or equal (\<=) 12 weeks before the first step-up dose of study treatment * Central nervous system involvement or clinical signs of meningeal involvement of MM. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic malignancies

Contacts and locations

Locations

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555, Japan

  • Kameda Medical Center

    Chiba, 296-8602, Japan

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151, Japan

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, 739-0696, Japan

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008, Japan

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701, Japan

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Ogaki Municipal Hospital

    Gifu, 503-8502, Japan

  • Osaka International Cancer Institute

    Osaka, 541 8567, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.