A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

NCT04696809 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CR10894964007957MMY1002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (4)

• Phase 1: Number of Participants with Adverse Events (AE)

  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

  Up to 1 year and 5 months

• Phase 1: Number of Participants with Serious Adverse Events (SAE)

  A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  Up to 1 year and 5 months

• Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)

  Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  Up to 28 days

• Phase 2: Overall response rate (ORR)

  ORR is defined as the percentage of participants who have a partial response (PR) or better according to the 2016 International Myeloma Working Group (IMWG) response criteria.

  Up to 1 year and 5 months

Secondary Outcomes (21)

• Phase 1 and Phase 2: Serum Concentration of Teclistamab

  Up to 1 year and 5 months

• Phase 1: Systemic Cytokine Concentrations

  Up to 1 year and 5 months

• Phase 1 and Phase 2: Number of Participants with Anti-teclistamab Antibodies

  Up to 1 year and 5 months

• Phase 1: Objective Response Rate

  Up to 1 year and 5 months

• Phase 1 and Phase 2: Duration of Response (DOR)

  Up to 1 year and 5 months

Study Arms (1)

Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM)

EXPERIMENTAL

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.

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered subcutaneously.

Also known as: JNJ-64007957

Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (15)

Kameda Medical Center

Chiba, 296-8602, Japan

Location

Ogaki Municipal Hospital

Gifu, 503-8502, Japan

Location

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, 311-3193, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650 0047, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Kyoto Kuramaguchi Medical Center

Kyoto, 603-8151, Japan

Location

National Hospital Organization Matsumoto Medical Center

Matsumoto, 399-8701, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

Location

Osaka International Cancer Institute

Osaka, 541 8567, Japan

Location

Japanese Red Cross Osaka Hospital

Osaka, 543-8555, Japan

Location

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, 739-0696, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

Location

Related Publications (1)

• Martin TG, Mateos MV, Yi JH, van de Donk NWCJ, Cai Z, Fu W, Garfall AL, Iida S, Jung SH, Kuroda Y, Niu T, Nooka AK, Min CK, Sidana S, Chastain K, Doyle M, Nishikawa K, Wang X, Song Y, Yamazaki H, Izumi Y, Zhuo J, Zhu A, Yoon DH, Du J, Ishida T. Efficacy and safety of teclistamab in triple-class exposed relapsed/refractory multiple myeloma: Pooled findings from three clinical cohorts and a retrospective cohort. Cancer. 2026 Jan 1;132(1):e70237. doi: 10.1002/cncr.70237.

  PMID: 41485109 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical trials

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: February 22, 2021
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (15)