A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)
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|ClinicalTrials.gov Identifier: NCT04557098|
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : August 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Drug: Teclistamab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||September 17, 2020|
|Estimated Primary Completion Date :||April 23, 2023|
|Estimated Study Completion Date :||August 7, 2024|
Experimental: Part 3: Teclistamab
Participants in all cohorts will receive teclistamab SC at an RP2D.
Teclistamab will be administered SC.
Other Name: JNJ-64007957
- Overall Response Rate (ORR) [ Time Frame: Up to 2.9 years ]ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
- Duration of Response (DOR) [ Time Frame: Up to 2.9 years ]DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to PD, whichever occurs first.
- Very Good Partial Response (VGPR) or Better Rate [ Time Frame: Up to 2.9 years ]VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
- Complete Response (CR) or Better Rate [ Time Frame: Up to 2.9 years ]CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
- Stringent Complete Response (sCR) Rate [ Time Frame: Up to 2.9 years ]sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
- Time to Response (TTR) [ Time Frame: Up to 2.9 years ]TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
- Progression-free Survival (PFS) [ Time Frame: Up to 2.9 years ]PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 2.9 years ]OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
- Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 2.9 years ]MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
- Number of Participants with AEs by Severity [ Time Frame: Up to 2.9 years ]Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
- Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values [ Time Frame: Up to 2.9 years ]Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
- Serum Concentration of Teclistamab [ Time Frame: Up to 3 months ]Serum concentrations of teclistamab will be reported.
- Number of Participants with Teclistamab Antibodies [ Time Frame: Up to 2.9 years ]Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
- Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) [ Time Frame: Baseline, up to 2.9 years ]The EORTC- QLQ-Core-30 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 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("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 higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
- Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to 2.9 years ]The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, 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). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.
- Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) [ Time Frame: Baseline, up to 2.9 years ]The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
- Overall Response Rate (ORR) in Participants with High-risk Molecular Features [ Time Frame: Up to 2.9 years ]ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557098
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|