A Study of Teclistamab in Combination with Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab and Lenalidomide (Tal-DR) in Participants with Newly Diagnosed Multiple Myeloma (MajesTEC-7)
- Conditions
- Multiple Myeloma
- Registration Number
- jRCT2031240014
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1590
'- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method