Clinical Trials /

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

NCT04696809

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).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Hematologic Malignancies

Interventions

DrugSynonymsArms
TeclistamabJNJ-64007957Japanese 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

NameTypeDescriptionInterventions
Japanese participants with relapsed or refractory multiple myeloma (MM)ExperimentalJapanese participants with relapsed or refractory MM will receive Teclistamab subcutaneously (SC) at two dose levels.
  • Teclistamab

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:Not yet recruiting
Lead Sponsor:Janssen Pharmaceutical K.K.

Last Updated

January 6, 2021