Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Teclistamab:Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.Teclistamab will be administered subcutaneously.
Pomalidomide, Bortez
Sponsors
Yamazaki Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio - Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line - Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria - Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 - A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment - Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion criteria
Exclusion criteria: - Received any prior B cell maturation antigen (BCMA)-directed therapy -A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib) - Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. - Received a live, attenuated vaccine within 4 weeks before randomization - Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis - Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Progression-free Survival (PFS) Up to 9 years PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first. Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity Up to 9 years Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to [>=] 38degrees Celsius); Grade 2: Fever (Temperature >=38degrees Celsius) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature >=38degrees Celsius) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature >=38degrees Celsius) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and 2: Overall Response (Partial Response [PR] or Better) Up to 9 years Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. Part 1 and 2: Very Good Partial Response (VGPR) or Better Response Up to 9 years VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. Part 1 and 2: Complete Response (CR) or Better Response Up to 9 years CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. Part 1: Duration of Response (DOR) Up to 9 years DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first. Part 1: Time to Next Treatment (TTNT) Up to 9 years TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Part 1: Progression-free Survival on Next-line Therapy (PFS2) Up to 9 years PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Part 1: Overall Survival (OS) Up to 9 years OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity Up to 9 years Number of participants with AEs by Severity will be reported. Part 1 and 2: Number of Participants with Serious Adverse Events (SAEs) by Severity Up to 9 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Spain, Sweden, Turkiye, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed