A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT04696809
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2021-02-22
2026-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM)
Japanese participants will receive Teclistamab subcutaneously (SC) at four dose levels. Cohort 1 will receive Teclistamab at Dose 1 and 2 (step-up doses) prior to first treatment dose on Day 1 followed by Dose 3 weekly (that is, on Days 1,8, and 15 of a 21-day cycle). Cohort 2 will receive Teclistamab at Dose 1 and 4 (step up doses) prior to first treatment dose on Day 1 followed by Dose 5 weekly. Cohort 3 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 6 weekly. Cohort 4 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 7 weekly for (2 cycles), then biweekly (cycle 3 to 6) on Days 1 and 15 and monthly (cycle 7) on Day 1 of 1 28-day cycle. In Phase 2 , participants will receive Teclistamab SC at Dose 1 and 4 (step up doses) up to 8 days prior to first treatment dose on Day 1 followed by Dose 5 on Days 1,8,15, and 22 of a 28-day cycle.
Teclistamab
Teclistamab will be administered subcutaneously.
Interventions
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Teclistamab
Teclistamab will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
20 Years
ALL
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical trials
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Kameda Medical Center
Chiba, , Japan
Ogaki Municipal Hospital
Gifu, , Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Kurume University Hospital
Kurume, , Japan
Kyoto Kuramaguchi Medical Center
Kyoto, , Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Japanese Red Cross Osaka Hospital
Osaka, , Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, , Japan
Japanese Red Cross Medical Center
Shibuya City, , Japan
Countries
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Other Identifiers
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64007957MMY1002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108949
Identifier Type: -
Identifier Source: org_study_id