NCT04696809CompletedPhase 1/2
A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 5 Jan 2021
- Start date
- 22 Feb 2021
- Primary completion date
- 13 Apr 2026
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Diseases
- Multiple myeloma
- NCT number
- NCT04696809
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 40
- From 22 Feb 2021 to the primary completion date, 13 Apr 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kameda Medical Center Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Ogaki Municipal Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| National Hospital Organization Mito Medical Center Coordinator of this site? Confirm its status | Higashiibaraki-gun | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| National Hospital Organization Kumamoto Medical Center Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Kyoto Kuramaguchi Medical Center Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| National Hospital Organization Matsumoto Medical Center Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Japanese Red Cross Osaka Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Hospital Organization Hiroshima-Nishi Medical Center Coordinator of this site? Confirm its status | Ōtake | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya City | Japan | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.