Description:
The purpose of the study is to evaluate the safety and tolerability in Japanese participants
with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D)
identified in Study 64007957MMY1001 (NCT03145181).
Title
- Brief Title: A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
- Official Title: A Phase 1 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
CR108949
- SECONDARY ID:
64007957MMY1002
- NCT ID:
NCT04696809
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Teclistamab | JNJ-64007957 | Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM) |
Purpose
The purpose of the study is to evaluate the safety and tolerability in Japanese participants
with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D)
identified in Study 64007957MMY1001 (NCT03145181).
Trial Arms
Name | Type | Description | Interventions |
---|
Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM) | Experimental | Japanese participants with relapsed or refractory MM will receive Teclistamab subcutaneously (SC) at three dose levels. Cohort 1 will receive Teclistamab at Dose 1 and Dose 2 (step-up doses) up to 10 days prior to the first treatment dose on Day 1 followed by Dose 3 on Days 1,8, and 15 of a 21-day cycle. Cohort 2 will receive Teclistamab at Dose 1 and Dose 4 (step up doses) up to 10 days prior to the first treatment dose on Day 1 followed by Dose 5 on Days 1,8, and 15 of a 21-day cycle. Cohort 3 will receive Teclistamab at Dose 1, Dose 4, and Dose 5 (step up doses) up to 10 days prior to the first treatment dose on Day 1 followed by Dose 6 on Days 1,8, and 15 of a 21-day cycle. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Adverse Events (AE) |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Serum Concentration of Teclistamab |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | Serum concentration of Teclistamab will be assessed. |
Measure: | Systemic Cytokine Concentrations |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | Cytokines concentration will be measured for biomarker assessment. |
Measure: | Number of Participants with Anti-teclistamab Antibodies |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | Number of participants with anti-teclistamab antibodies will be assessed. |
Measure: | Objective Response Rate |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | Objective response will be defined as partial response (PR) or better as defined by the International Myeloma Working Group (IMWG) response criteria in multiple myeloma (MM). |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | DOR is defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death. |
Measure: | Time of Response (TTR) |
Time Frame: | Up to 1 year and 5 months |
Safety Issue: | |
Description: | TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation that the participant has met all criteria for PR or better. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Janssen Pharmaceutical K.K. |
Last Updated
August 20, 2021