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
