Clinical trial NCT04696809: A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hematologic Malignancies
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Phase 1: Number of Participants with Adverse Events (AE)
timeFrame: Up to 1 year and 5 months
measure: Phase 1: Number of Participants with Serious Adverse Events (SAE)
timeFrame: Up to 1 year and 5 months
measure: Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
timeFrame: Up to 28 days
measure: Phase 2: Overall response rate (ORR)
timeFrame: Up to 1 year and 5 months
Secondary outcomes:
measure: Phase 1 and Phase 2: Serum Concentration of Teclistamab
timeFrame: Up to 1 year and 5 months
measure: Phase 1: Systemic Cytokine Concentrations
timeFrame: Up to 1 year and 5 months
measure: Phase 1 and Phase 2: Number of Participants with Anti-teclistamab Antibodies
timeFrame: Up to 1 year and 5 months
measure: Phase 1: Objective Response Rate
timeFrame: Up to 1 year and 5 months
measure: Phase 1 and Phase 2: Duration of Response (DOR)
timeFrame: Up to 1 year and 5 months
measure: Phase 1 and Phase 2: Time to Response (TTR)
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Very Good Partial Response (VGPR) or Better Response Rate (Stringent Complete Response [sCR]+ Complete Response [CR]+VGPR)
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Complete Response (CR) or Better Response Rate
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Stringent Complete Response (sCR) Rate
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Progression-free Survival (PFS)
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Overall survival (OS)
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Minimal Residual Disease (MRD)-negative Rate
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with AEs
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with AEs by Severity
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with SAEs
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with SAEs by Severity
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values by Severity
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Change from Baseline in EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) Scale
timeFrame: Up to 1 year and 5 months
measure: Phase 2: Change from Baseline in Patient Global Impression of Severity (PGIS) Scale
timeFrame: Up to 1 year and 5 months
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Kameda Medical Center
city: Gifu
country: Japan
facility: Ogaki Municipal Hospital
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kumamoto shi
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: Kyoto Kuramaguchi Medical Center
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Nagoya City
country: Japan
facility: Nagoya City University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Otake
country: Japan
facility: National Hospital Organization Hiroshima-Nishi Medical Center
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical trials
role: STUDY_DIRECTOR
References: