a study of teclistamab in japanese participants with relapsed or refractory multiple myeloma

Conditions: Hematologic Malignancies

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