A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy (MajesTEC-7)
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)
Nakama Takahiro
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Medical Information Center
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Recruiting
June. 28, 2024
June. 14, 2024
1590
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
'- 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
18age old over
No limit
Both
Multiple Myeloma
Teclistamab-Teclistamab, Daratumumab SC, Lenalidomide (Tec-DR)
Teclistamab will be administered as SC injection.
Daratumumab -
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Daratumumab will be administered as SC injection.
Lenalidomide -
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Lenalidomide will be administered orally.
Dexamethasone - Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Dexamethasone will be administered either orally or intravenously (IV).
Talquetamab -
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Talquetamab will be administered as SC injection.
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.
'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 pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse
Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: lifethreatening, and Grade 5: death related to adverse event.
Number of Participants with Abnormalities in Laboratory Parameters - From randomization up to 9 years
Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
Number of Participants with Abnormalities in Vital Signs - From randomization up to 9 years
Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
Number of Participants with Abnormalities in Physical Examination - From randomization up to 9 years
Number of participants with abnormalities in physical examination will be reported.
Number of Participants with Abnormalities in Electrocardiogram (ECG) - From randomization up to 9 years
Number of participants with abnormalities in ECG will be reported.
Serum Concentrations of Teclistamab and Talquetamab - From randomization up to 9 years
Serum samples will be analyzed to determine concentrations of teclistamab and Talquetamab using validated, specific, and sensitive methods.
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab - From randomization up to 9 years
Number of participants with ADAs to teclistamab and talquetamab will be reported.
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) - From baseline up to 9 years
The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss,
constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days (past week), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher
response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item
represents a high level of symptomatology/problems.
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) -Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
The National Cancer Institutes (NCIs) PROCTCAE
is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as
Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) - From baseline up to 9 years
The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating health today with anchors ranging
from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL - From randomization up to 9 years
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted.
NCT05552222
ClinicalTrials.gov
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