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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04696809
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Pharmaceutical K.K.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Pharmaceutical K.K., Japan Clinical trials
Principal Investigator Affiliation Janssen Pharmaceutical K.K.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hematologic Malignancies
Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Teclistamab

Teclistamab will be administered subcutaneously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kameda General Hospital, Chiba, Japan

Status

Recruiting

Address

Kameda General Hospital

Chiba, , 296-8602

Ogaki Municipal Hospital, Gifu, Japan

Status

Recruiting

Address

Ogaki Municipal Hospital

Gifu, , 503-8502

Higashiibaraki-gun, Japan

Status

Recruiting

Address

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, , 311-3193

Hyogo, Japan

Status

Recruiting

Address

Kobe City Medical Center General Hospital

Hyogo, , 650-0047

Kumamoto-shi, Japan

Status

Recruiting

Address

National Hospital Organization Kumamoto Medical Center

Kumamoto-shi, , 860-0008

Kurume University Hospital, Kurume, Japan

Status

Recruiting

Address

Kurume University Hospital

Kurume, , 830-0011

Kyoto Kuramaguchi Medical Center, Kyoto, Japan

Status

Recruiting

Address

Kyoto Kuramaguchi Medical Center

Kyoto, , 603-8151

Matsumoto, Japan

Status

Recruiting

Address

National Hospital Organization Matsumoto Medical Center

Matsumoto, , 399-8701

Nagoya City University Hospital, Nagoya-City, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya-City, , 467-8602

Niigata Cancer Center Hospital, Niigata, Japan

Status

Recruiting

Address

Niigata Cancer Center Hospital

Niigata, , 951-8566

Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama, , 701-1192

Osaka International Cancer Institute, Osaka, Japan

Status

Recruiting

Address

Osaka International Cancer Institute

Osaka, , 541-8567

Japanese Red Cross Osaka Hospital, Osaka, Japan

Status

Recruiting

Address

Japanese Red Cross Osaka Hospital

Osaka, , 543-8555

Hiroshima West Medical Center, Otake, Japan

Status

Recruiting

Address

Hiroshima West Medical Center

Otake, , 739-0696

Japanese Red Cross Medical Center, Shibuya, Japan

Status

Recruiting

Address

Japanese Red Cross Medical Center

Shibuya, , 150-8935