Multiple Myeloma
Conditions
Interventions
Teclistamab-Teclistamab, Daratumumab SC, Lenalidomide (Tec-DR)
Teclistamab will be administered as SC injection.
Daratumumab -
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Talquetamab, Dara
Sponsors
Nakama Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: '- Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria - Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment - Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 - A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment - A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion criteria
Exclusion criteria: - Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone within 14 days before randomization - Had plasmapheresis within 28 days of randomization - Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization - Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients - Known contraindications to the use of daratumumab or lenalidomide per local prescribing information - Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) From randomization to the date of disease progression or death (Up to 9 years) PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria. 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) At Month 12 12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria. Complete Response (CR) or Better From randomization up to 9 years CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 'Very Good Partial Response (VGPR) or Better - From randomization up to 9 years VGPR or better is defined as the percentage of participants achieving VGPR and CR (including sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. Complete Response (CR) or Better From randomization up to 09 years CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. Sustained Minimal Residual disease (MRD)-negative Complete Response (CR) - From randomization up to 9 years Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between. MRD-negative CR - From randomization up to 9 years MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better. Progression Free Survival on Next-line Therapy (PFS2) - From randomization 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 that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. Overall Survival (OS) - From randomization to the date of death (up to 9 years) OS is defined as the time from the date of randomization to the date of death due to any cause. Number of Participants with Adverse Events (AEs) by Severity - From randomization up to 9 years An adverse event is any untoward medical occurrence in a clinical study participant administered a | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Korea,Republic Of, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed