Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
Conditions
Interventions
Intervention1: Teclistamab: At Cycle 1, participant will receive 3mg or 4 mg step up dose on Day1 and 15mg or 25 mg on Day 3 for body weight less than 60 kg and greater than 60 kg then 100mg or 150 m
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. 2. Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria. 3. Measurable disease at Screening as defined by any of the following: a)Serum M-protein level =0.5 g/dL (central laboratory); or b) Urine M-protein level =200 mg/24 hours (central laboratory); or c) Serum immunoglobulin free light chain =10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio 5. Have an ECOG performance status score of 0 to 2 6. Have clinical laboratory values meeting the protocol required criteria during the Screening Phase 7. Relapsed or refractory disease as defined below: a. Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria during previous treatment or =60 days after cessation of treatment. 8. Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line.
Exclusion criteria
Exclusion criteria: 1.Received any prior BCMA-directed therapy, pomalidomide therapy, carfilzomib therapy. 2.Does not meet criteria for bortezomib retreatment 3. Grade 1 peripheral neuropathy with pain or Grade =2 peripheral neuropathy as defined by NCI-CTCAE Version 5.0 4. Received a strong CYP3A4 inducer within 5 half-lives prior to randomization. 5. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) according to IMWG.Timepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete responseTimepoint: 12 Months;Duration of responseTimepoint: 12 Months;MRD negativityTimepoint: 12 months;Overall responseTimepoint: 12 Months;Overall survivalTimepoint: 12 Months;Time to next treatmentTimepoint: 12 Months;Time to worsening of symptomsTimepoint: 12 Months | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Spain, Sweden, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson & Johnson
Outcome results
None listed